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Medical deviceproduct catalog
2016www.ccd-lab.com
Gynecology
Antenatalscreening
AssistedReproductiveTechnology
Your sales representative
Export department Phone: + 33 (0) 3 44 26 89 51 – Fax + 33 (0) 3 44 26 57 42
www.ccd-lab.com [email protected]
Laboratoire CCD 48 rue des Petites Ecuries – 75010 Paris – France
Laboratoire CCD has a central position in Assisted Reproductive Technology andGynecology. With over 30 years of products development and manufacturingexperience, Laboratoire CCD has become a pivotal actor in the medical device fieldfor womens’ health and human reproduction, in France and around the world.
Laboratoire CCD is an expert in plastic processing applied to medical devices, fromextrusion to moulding. Our important know-how is key to explore the mostdemanding technical areas of our customers. Laboratoire CCD is proud to offerqualitative and technically advanced products for all these medical procedures.
Our devices are developped and made in France, to offer our customers the bestproducts in terms of quality, performance, reliability and added-value.
With both our latest achievements and our core product lines that have becomeworldwide references, we focus on using state-of-the-art processing techniques andbest-in-class design methods, to provide complying and qualitative devices to ourcustomers.
We are proud to be the partner of professional distributors in more than 80 countries.We are confident you are to find the right product through our network ofrepresentatives. They will be provided with the service and quality you deserve.
For further information, please contact our local representative or our exportdepartment - see below.
Edito
Contents
FUNCTIONAL EXPLORATION3 Cusco type speculum
Collin type speculum4 Hysterometer5 Gradual dilator by Dubreuil6 Retrievette®
7 Ultrasound probe cover
PAP SMEARS8 Duo-Brush®
9 Scrinet®
ENDOMETRIAL SMEARS10 Endobrush®
11 Endocyte®
ENDOMETRIAL BIOPSY12 Pipelle de Cornier®
Pipelle de Cornier® Mark II13 Pipelle® H
SALINE INFUSION SONOHYSTEROGRAPHY14 Siscone®
15 Rudigoz catheter
HYSTEROSALPINGOGRAPHY16 Sliding Rigister®
17 Sift® syringeBloc connector
Gynecology1
ACCESSORIES21 Sperm collection vial
Spirette®
INTRA-UTERINE INSEMINATION22 IVF & IUI syringe23 Catheters for intra-uterine insemination
ART19
Antenatal screening35
Obstetrics41
OVUM PICK-UP24 OPS® ART of CCD® sets25 OPS® Classic sets26 Needle Ovo® ART of CCD®
Needle Ovo® Classic27 OPS® a collection vial
EMBRYO TRANSFER
Sets for embryo transfer28 Seren® ET29 Full Echo® Pro 30 Frydman® Ultrasoft Echo31 TDT® set
Catheters for embryo transfer32 Frydman® Memory33 Frydman® Classic
AMNIOCENTESIS37 Needles for amniocentesis and cordocentesis
CHORIONIC VILLUS SAMPLING 38 CVS set39 Blache needle
ACCESSORIES40 ABC system
AMNIOTIC MEMBRANE PERFORATOR43 Amniopic®
Certificates
ISO 9001 : 2008ISO 13485 : 2003NF EN ISO 13485 : 2012
Valid from: July 30th, 2015Valid until: July 29th, 2018
CERTIFICATES OF REGISTRATION
ISO 13485 : 2003CMDAS (Canada)
Valid from: July 30th, 2015Valid until: July 29th, 2018
Sterile and non-sterile medical devicesfor Assisted Reproductive Technologysistance Médicale à la Procréation
Valid from: July 30th, 2015Valid until: July 29th, 2018
EC CERTIFICATES
Sterile medical devices for AssistedReproductive Technology
Valid from: July 30th, 2015Valid until: July 29th, 2018
These certificates are available online on the website www.ccd-lab.com or on request by mail at [email protected]
French design and manufacturing
The products sold by Laboratoire CCD are manufactured mainly in France.
R&D teams developinnovative products, tomeet customers’ needs.
The manufacturing plant masters allproduction techniques:
extrusion, moulding, overmoulding.
During the manufacturingprocess, the products areregularly controled. Some references are evencontrolled at 100%.
CE markings and symbolsused on the packagings
CE marked device
Single use - Do not reuse
Read intructions for use
Device sterilised by irradiation
Device sterilised by ethylene oxide
Non sterile
Manufacturing date
Manufacturer
Expiry date
Reference of the device
Batch number
Store in a dry place
Keep away from light
Sterilisation: ethylene oxide or irradiation ?
To sterilise medical devices, two techniques are mainly used by industrials: ethylene oxide (EtO)and irratiation. These two technics present different characteristics. It is important to select thesterilisation technique adapted to the type of medical device that needs to be sterilised.
Products sterilised with EtO will have to undergo a ventilation cycle to remove gas residues. Theremaining residues are controlled at the end of the cycle and must comply with internationalregulations.
Irradiation involves exposing the products to radiations. With this technique, you are 100% surenot to have EtO cytotoxic residues. As this may result in some material degradation issues, it cannot be used for all devices.
Laboratoire CCD has chosen to use these two techniques to sterilise its medical devices:
Ethylene oxide for medical devices in contact with adult patients.
These product present on their packagings the symbol
Irradiation for all devices used in Assisted Reproductive Technology (ART), that willbe in direct contact with reproductive cells (sperm and oocyte) or with embryos. Asthese cells are sensitive to their environment, Laboratoire CCD favours this techniqueto ensure the sterilisation of the devices will have no impact on cells development.
These products present on their packagings the symbol
Tests realised on ART medical devices
Endotoxin testing (LAL) and MEA testing
Laboratoire CCD routinely performs MEA and LAL testings on the medical devices for ART:embryo transfer catheters, ovum pick-up needles and sets, and IUI catheters.
MEA testing (Mouse Embryo Assay)
Biological test on one- or two-cells mouse embryos to confirm the devices that come in contactare not cytotoxic for the embryos. The quality of the embryo is assessed after a contact periodof 72, 96 and 120 hours, with the device. 70% of one-cell embryos or 80% of 2-cells embryosmust have reached the blastocyst stage for the test to be positive.
Endotoxin testing
Quantitative test to detect if there are bacterial endotoxins on the medical devices.
With these testings, Laboratoire CCD is sure to provide ART devices not to affect the developmentand survival of the reproductive cells or embryos.
Standards applicable to medical devices
Laboratoire CCD conceives and manufactures medical devices according to a set of internationalISO standards, as for example:
ISO 10993-3:2003
Standard for biological evaluation of medical devices to ensure the absence of genotoxic andcarcinogenic risks, and the absence of toxicity on reproduction and development.
ISO 10993-5:2009
Standard for the evaluation methods used to assess the in vitro toxicity of medical devices. It isused to assess the in vitro biological response of mammal cells in contact with the device, and tomake sure this device will have no harmful effects on the cells.
ISO 11135-1:2007
Standard for the ethylene oxide sterilisation of medical devices (development, validation, androutine checks).
ISO 11137-1:2006
Standard for the irradiation sterilisation of medical devices (development, validation, and routinechecks).
ISO 11607-1:2006
Standard for the development of a sterile barrier protection around the medical devices, and themaintain of this protection until their point of use. It ensures the medical devices are sterile whenthe packaging is open, so long the packaging has not been damaged.
ISO 13485:2003
Standard for management quality systems. It ensures the manufacturer put on the marketmedical devices compliant with customers requirements and compliant with the regulatoryrequirements on medical devices.
ISO 9001:2008
Standard for quality system management, proving the manufacturer is able to offer a productconform to customer requirements as well as regulatory requirements, and the manufacturer isengaged in a continuous improvement process in order to increase customer satisfaction.
New ordering references
To improve its logistic management and provide better service to its customers,Laboratoire CCD has chosen to work with SAP software. As a result, the codes used toorder products are to change.
To help you, you may find a lookup table, where old and new codes are both provided.This table can be found at the end of this catalog.
The products remain the same, only their ordering references have been changed.
Information in this brochure is exact at the date of impression. Nevertheless, Laboratoire CCD may modify and improve this catalog and its information at any time. © CCD 2016. All rightsof translation, adaptation and reproduction by any means reserved for all countries. Any representation of complete or partial reproduction, by any process whatsoever, made without theconsent of the authors or their successors is unlawful and constitutes an infringement punishable by articles L 335-2 of the Code of intellectual property. Non-contractual photos. ®Trademark.Photo credit : Stocklib, CCD
Gynecology
From the Pipelle de Cornier for endometrial biopsy tothe Siscone for sonohysterography, Laboratoire CCD has been developing new innovativeproducts for many years, in partnership with physicians,to answer their needs and improve the quality ofgynecological examinations.
1.Gynecology
1
1
2
Cusco type speculumCollin type speculumFor a visual access to the cervix and the vagina
Cusco-type speculums are intransparent plastic. They offer a goodvisual access for the physician and animproved comfort for the patient incomparison with metal speculum, asthey prevent the patient from thermalshock.
Cusco-type speculums are available in3 sizes, adapted to fit all patientsmorphologies. The safety screw allowsa quick release of the device.
The Collin-type speculum features twoindependant valves, that will leave a largepassage for the instrumentations during anexamination or a medical interventions.
DESIGNATION ORDERREFERENCE DIAMETER LENGTH SCREW COLOUR PACKAGING
Cusco-type speculum
7004684 16 mm 10 cm l vert 100 /box7004685 24 mm 10 cm l bleu 100 /box7004686 30 mm 10 cm l blanc 100 /box
Collin-type speculum 7002702 30 mm 10 cm l gris 10 /box
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Sterile class I medical devices.Manufacturer of Collin-type speculum : Laboratoire CCD - CE0459.Manufacturer of Cusco-type speculum : Oiarso Medical - CE 0123.Read instructions for use. Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
FUNCTIONAL EXPLORATION1. GYNECOLOGY
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To measure uterus length
The flexible hysterometers are graduated everycentimeter from the distal tip, over 15 cm. Madeof polyethylene, they can be curved beforeintroduction to facilitate the passage of thecervix.
DESIGNATION ORDERREFERENCE SIZE TOTAL
LENGTHEFFECTIVELENGTH PACKAGING
Flexible hysterometer
7002736 CH 10 30 cm 15 cm 25 /box7002737 CH 12 30 cm 15 cm 25 /box7002738 CH 14 30 cm 15 cm 25 /box
4
Flexible hysterometer
Sterile class I medical devices.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
FUNCTIONAL EXPLORATION1. GYNECOLOGY
Gradual dilator by DubreuilProgressive cervix dilation before hysteroscopy
The distal portion includes 4 or 5 segments(depending on the reference) of 1,5 cm each, withgradually increasing diameter from the distal tip.
Each segment fits over the truncated end of theprevious one to avoid sharp edges.
DESIGNATION ORDERREFERENCE
DILATION SEGMENTSDIAMETERS
LENGTH OF THEINTRA-CERVICAL SECTION
PACKAGING
Dilator - Small model 7002710 5 - 6 - 7 - 8 mm 6,5 cm 10 /boxDilator - Large model 7002711 8 - 9 - 10 - 11 - 12 mm 8,5 cm 10 /box
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Sterile class I medical devices.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
FUNCTIONAL EXPLORATION1. GYNECOLOGY
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IUD thread retriever
The Retrievette is used to grab the thread or body ofan intrauterine device to remove it.
Polypropylene device with:
• a concave section with 3 notches and a rounded tip,
• a handle, in the lower section, to facilitate themanipulation of the device.
While rotating the Retrievette and pressing it gentlyagainst the wall of the uterus, the IUD’s thread ishooked into the notches and pulled out through thecervix when the Retrievette is withdrawn.
DESIGNATION ORDERREFERENCE PACKAGING
Retrievette 7002701 10 /box
6
Retrievette
Sterile class I medical devices.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
1. GYNECOLOGYFUNCTIONAL EXPLORATION
FUNCTIONAL EXPLORATION
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Ultrasound probe cover
Protection against viral and bacterial contaminations
The ultrasound probe cover is made of non-poweredand non-lubricated latex, for use with all models ofendovaginal probe.
Class II medical device - non sterile.Manufacturer : Pleasure Latex Products – CE 0120.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
DESIGNATION ORDERREFERENCE LENGTH DIAMETER THICKNESS PACKAGING
Ultrasound probe cover 7004820 180 - 190 mm 52 mm 0,065 mm 72 /box
1. GYNECOLOGY
Duo-BrushEndo- and exocervix sampling in one single procedure
Ergonomic device featuring two brushes at an 90°angle. The Duo-Brush provides atraumatic accessto the cervix with its central brush, and sweepingswab of the exocervix surface with its lateralbrush.
It can be used for classic pap smear on amicroscope slide or on liquid medium.
DESIGNATION ORDERREFERENCE
CENTRALBRUSHLENGTH
LATERALBRUSHLENGTH
TOTALLENGTH PACKAGING
Duo-Brush 7002604 2,5 cm 1 cm 23,2 cm 25 /box
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Sterile class I medical devices.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
1 single rotation
Also available non-sterile (packaging : 250/box) : 7002605
1. GYNECOLOGYPAP SMEAR
PAP SMEAR
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ScrinetFor endocervical cytology or bacteriological sampling
The Scrinet is made of a cylindrical polyamidebrush and a long polypropylene handle.
It is designed to perform endocervical smear forcervical cancer screening or bacterial infectionscreening.
DESIGNATION ORDERREFERENCE DIAMETER PACKAGING
Scrinet 3 mm 7002591 3 mm 50 /boxScrinet 5,5 mm 7002592 5,5 mm 50 /box
Sterile class I medical devices.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
Also available non sterile (packaging : 250/box): - Scrinet 3 mm : 7002593- Scrinet 5,5 mm : 7002594
1. GYNECOLOGY
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
ENdOMETRIAL SMEAR
EndobrushEndometrial cytology
Diamond-shape brush, designed to collect cells atthe surface of the endometrium.
The brush can be entirely retracted in its sheath,closed by a rounded cap.
➔ Atraumatic during passage of the cervix.
➔ Protection of the brush against contaminationsduring cervix passage.
DESIGNATION ORDERREFERENCE SAMPLING SYSTEM TOTAL
LENGTH PACKAGING
Endobrush 7002608Diamond-shape brushLength: 2 cmMax. diameter: 15 mm
23,5 cm 25 /box
1. GYNECOLOGY
ENdOMETRIAL SMEAR
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EndocyteEndometrial cytology
Original sampling system with a V-shape blade.
Endocyte provides adequate endometrial smearfor endometrial cancer screening or bacterialinfection screening, using a simple procedurerequiring no traction nor dilation.
The V-shape double blade is protected by a distalsphere obturating the sheath during cervixpassage.
DESIGNATION ORDERREFERENCE SAMPLING SYSTEM TOTAL
LENGTH PACKAGING
Endocyte 7002586 V-shape double blade 21,6 cm 25 /box
Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
1. GYNECOLOGY
Pipelle de CornierPipelle de Cornier Mark II
Endometrial biopsy by aspiration, for an efficient diagnosis of endometrial cancer
The Pipelle de Cornier is the reference ingynecological practice for the diagnosis ofendometrial cancer. Its aspiration level providessamples of a good quality for analysis.
The Pipelle de Cornier Mark II, an evolution of thePipelle de Cornier, underwent a surface treatmentat the tip to allow collecting cells at the surface ofthe endometrium, thus providing samples forcytology and histology in a single procedure.
DESIGNATION ORDERREFERENCE EXT.Ø INT.Ø LENGTH LATERALEYE Ø SAMPLING TYPE PACKAGING
Pipelle de Cornier 7002588 3,1 mm 2,6 mm 23,5 cm 2,1 mm histology 25 /boxPipelle de CornierMark II 7002716 3,1 mm 2,6 mm 23,5 cm 2,1 mm histology
+ cytology 25 /box
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
1. GYNECOLOGYENdOMETRIAL BIOPSY
ENdOMETRIAL BIOPSY
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Pipelle HHistological sampling during hystéroscopy
Based on the original Pipele de Cornier device,the Pipelle H optimises endometrium samplingwhen performing a diagnostic hysteroscopy. With a 50 cm length the Pipelle H producesenough suction to collect a large volume ofendometrial tissue, despite the presence of thedistension liquid, and without having to repeatthe procedure several times.
The diameter of the Pipelle H allows itsintroduction through the working channel of thehysteroscope up to the uterine fndus. A biopsy isthen performed in the usual fashion.
DESIGNATION ORDERREFERENCE EXT.Ø INT.Ø LENGTH LATERALEYE Ø SAMPLING TYPE PACKAGING
Pipelle H 7002606 3,1 mm 2,6 mm 50 cm 2,1 mm histologie 10 /box
Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
1. GYNECOLOGY
SONOHYSTEROGRAPHY
Siscone®
Injection of saline solution with leakage-free system for saline sonohysterography
Siscone® allows injection of a saline solution inthe uterus to improve uterine cavity visibilityunder ultrasound scanning. A mobile cone in silicone is used to seal thecervix and prevent risks of liquid reflux, withoutimpairing the vision.
Siscone® can be preshapped and curved beforeinsertion to facilitate its passage through thecervix.
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
DESIGNATION ORDERREFERENCE EXT.Ø INT.Ø LENGTH OPENING
INSERTIONDEPTHMARKINGS
PACKAGING
Siscone 7002620 2,1 mm 1,1 mm 19 cm distal 5 and 6 cm 10 /box
1. GYNECOLOGY
SONOHYSTEROGRAPHY
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Rudigoz catheterInjection of saline solution for sonohysterography
Cathéter designed to improve the visualisation ofuterine cavity under ultrasound scanner byinjection of a saline solution in the uterus.
Soft distal tip over the last 2 cm in order to respectthe uterine lining.
DESIGNATION ORDERREFERENCE EXT.Ø INT.Ø LENGTH OPENING
INSERTIONDEPTHMARKINGS
PACKAGING
Rudigozcatheter 7002690 2,1 mm 1,7 mm 19 cm distal 3 and 4 cm 25 /box
Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
1. GYNECOLOGY
HYSTEROSALPINGOGRAPHY
Sliding RigisterEffective and easy injection of contrast medium
Device for hysterosalpingography and test withmethylene blue, comprising:
• a tapered and transparent cup with a central cone-shaped cannula and a lateral tubing that can beconnected to a vacuum system. The overall systemensures complete watertighness around the cervixand absence of contrast medium leakage.
• a central tubing with a stopcock at its proximal tip,to inject contrast medium. The tubing slides insidethe cup to facilitate cervical insertion.
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
DESIGNATION ORDERREFERENCE CUP Ø TUBING FEATURE PACKAGING
Sliding Rigister
7002694 20 mm mobile 10 /box7002695 25 mm mobile 10 /box7002696 30 mm mobile 10 /box7002697 35 mm mobile 10 /box
1. GYNECOLOGY
1. GYNECOLOGYHYSTEROSALPINGOGRAPHY
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Sift syringe+ Bloc connector Accessoiries for hysterosalpingography
The SIFT syringe is a 3-piece syringe with ascrew to inject contrast medium regularly andwithout reflux.
It is a useful accessory to the Sliding Rigister.
DESIGNATION ORDERREFERENCE VOLUME MARKINGS CONNECTION PACKAGING
Sift syringe 7002705 20 ml 1 ml Male Luer-lock 10 /box
The Bloc Connector is a maleLuer-lock / cone adaptor used to connect avacuum system to the cup of the SlidingRigister.
DESIGNATION ORDERREFERENCE PACKAGING
Bloc Connector 7002704 25 /box
Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
18
2.ART
2 ART
For more than 30 years, Laboratoire CCD has been the partner of physicians and biologists tohelp couples who desire to have children.
From the IUI catheters to the embryo transfer cathetersand ovum pick-up sets, Laboratoire CCD makes its bestto offer high quality and innovative products to meetthe best medical practices and technologyadvancement.
19
20
2. ARTACCESSORIES
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Sperm collection vial: Class IIa medical device.Spirette : sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
Sperm collection vialTransparent polymer vial, with a stem, a base anda lid, to collect semen in laboratory.
The graduated base provides quick evaluation ofthe volume of semen collected.
SpiretteCatheter for cervical mucus sampling.
The aspiration is done by pulling the internalplunger. This system does not require the use of asyringe for aspiration.
DESIGNATION ORDERREFERENCE WEIGHT PACKAGING
Sperm collection vial 7002614 33,03 g 25 /box
DESIGNATION ORDERREFERENCE EXT. Ø INT. Ø LENGTH PACKAGING
Spirette 7002590 3,1 mm 2,6 mm 23,5 cm 25 /box
2. ARTINTRA-UTERINE INSEMINATION
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Class IIa medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
IVF & IUI syringe
A Luer-slip1 mL syringe composed of 3 parts.
This syringe is adapted to ART procedures as it issterilised by irradiation.
It can be connected to IUI catheters for injectionof fresh sperm, or to embryo transfer catheters.
DESIGNATION ORDERREFERENCE VOLUME PACKAGING
IVF & IUI syringe 7002655 1 mL 25 /boîte
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ARTINTRA-UTERINE INSEMINATION
IUI cathetersA range of catheters adapted to different needs
The IUI catheters have an atraumatic blunt-endtip and two lateral openings to release the spermclose to the tubal ostia.
The standard catheter and the Genitor® catheterhave a very soft tip to reach the uterine cavitywithout trauma.
The malleable catheter has a guidewireembedded in its wall, to facilitate the passage oftight or stenotic cervixes.
DESIGNATION ORDERREFERENCE
TOTALLENGTH
SOFT TIPLENGTH
INTERNALVOLUME INT. Ø EXT. Ø PACKAGING
StandardIUI catheter 7002726 17 cm 4,5 cm 0,40 ml 1,70 mm 2,10 mm 25 /box
GenitorIUI catheter 7002725 17 cm 4,5 cm 0,10 ml 1,65 mm 1,60 mm 25 /box
MalleableIUI catheter 7002728 17 cm N/A 0,27 ml 1,10 mm 2,10 mm 25 /box
2. ARTOVUM PICK-UP
OPS ART of CCD setsPremium pre-connected sets for ovum pick-up
Set comprising of a high quality ART of CCD needle withechogenic markings (cf. page 26 for the needle features),kink-resistant polyurethane tubings, and cap for awatertight connection to the OPS collection vials. Thesesets limit the risk of fracturing the zona pellucida bycontrolling the aspiration with the use of a pump.
The OPS ART of CCD sets are available both in versionswithout stopcock, or with stopcock for follicle flushingtechnique.
DESIGNATION ORDERREFERENCE STOPCOCK
TUBINGS CAPPACKAGING
LENGTH INT. Ø EXT. Ø TYPE COMPATIBILITY
OPS ART of CCD
7002640 yes100 cm 1,1 mm 2 mm Silicone
cone15 mL Falcon-type vial 10 /box
7002639 no
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Class IIa medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
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Class IIa medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ART
OPS Classic setsPre-connected sets for ovum pick-up
Sets comprising a Classic needle (cf. page 26 for needlefeatures), kink-resistant polyurethane tubings, and cap fora watertight connection to the OPS collection vials.These sets can be connected to an oocyte aspiration pumpthanks to their Luer connectors.
The OPS Classic sets are available both in versions withoutstopcock, or with stopcock for follicle flushing technique.
DESIGNATION ORDERREFERENCE STOPCOCK
TUBINGS CAPPACKAGING
LENGTH INT. Ø EXT. Ø TYPE COMPATIBILITY
OPS Classic
7002625 yes60 cm 1,1 mm 2 mm Silicone
cone15 mL Falcon-type vial 10 /box
7002624 no
OVUM PICK-UP
2. ART
Ovo ART of CCD needleOvo Classic needleHigh quality needles for ovum pick-up
Ovo ART of CCD needle: single-lumen needle, triplebevel, echogenic by engravings, specially designed forovum pick-up. The needle has a Luer-lock proximal tipto connect a syringe.
The high quality medical grade steel facilitateshandling and sliding of the needle through the tissues.The sharp bevel sticks the tissues without tearingthem.
The engravings at the tip of the needle ensures optimalechogenicity of the needle tip.
The best needle CCD can offer for your ovum pick-ups.
Classic needle: single-lumen needle, double-bevel, with sand-blasted echogenic tip.
An economical choice with very good quality/ priceratio.
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Class IIa medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
DESIGNATION ORDERREFERENCE
TOTALLENGTH ECHOGENICITY INT. Ø EXT. Ø PACKAGING
Ovo ART ofCCD needle 7002645 30 cm Laser marking 1,0 mm 1,4 mm
G 17 10 /boxOvo Classicneedle 7002691 30 cm Sand-blasting 1,2 mm 1,4 mm
G 17 10 /box
OVUM PICK-UP
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Manufacturer: SARSTEDT In-vitro Product.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. AMP
OPS vialsVials adapted to the OPS sets
Oocyte collection vials, transparent, with screw cap, to collectand transport the oocytes. These vials are compatible withthe OPS and HOC sets.
They can be stored in incubators to keep the embryos at theright temperature.
The OPS vial is a 15 mL Falcon-type vial, with a roundedbottom.
The HOC vial has a flat bottom, and can be store vertically. Its30 mL volume 30 mL allows collection of a larger number ofoocytes in the same vial.
DESIGNATION ORDERREFERENCE VOLUME DIAMETER LENGTH PACKAGING
OPS vial 7002761 15 ml 17 mm 12 cm 50 /box
OVUM PICK-UP
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ART
Seren ET Safe and secure embryo transfer,
at the forefront of innovation in embryo transfer
Set in 3 parts, consisting of:
• a malleable insertion sheath with shape memoryand ergonomic funnel entry
• an obturating stylet
• a soft catheter, echogenic on its whole length
Seren ET will allow you to pass all types of cervicalprofiles, and to avoid the use of trial catheter to testthe passage. Its unique design with the funnel hubintroduction sheath facilitates catheter insertion toreduce transfer time and embryo exposure to thesurounding environment.
Both the insertion sheath and the catheter areechogenic on their whole length, to control theiradvancement and position under ultrasoundguidance.
EMBRYO TRANSFERSets for embryo transfer
DESIGNATION ORDERREFERENCE
INSERTION SHEATH CATHETERECHOGENIC PACKAGING
TYPE EXT. Ø LENGTH EXT. Ø INT. Ø
Seren ET 7004319 malleable 2,7 mm 21 cm 1,5 mm 0,5 mm yes 10 /box
Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ART
Full Echo Pro Echogenic and malleable set for embryo transfer,
for a complete control of the procedure
Set in 3 parts, consisting of:
• a malleable insertion sheath with shape memory
• an obturating stylet
• a soft catheter, echogenic on its whole length
The obturating stylet will protect the internal lumenof the insertion sheath from mucus contaminationduring cervix passage. Thus, the embryo will beprotected against cervical contaminations during thetransfer.
The echogenic insertion sheath with shape memorymakes it possible to pass all cervical profiles, eventhe most difficult ones.The exact position of the catheter and sheath can becontrolled by ultrasound, as they are both echogenicon their whole length.
EMBRYO TRANSFERSets for embryo transfer
DESIGNATION ORDERREFERENCE
INSERTION SHEATH CATHETERECHOGENIC PACKAGING
TYPE EXT. Ø LENGTH EXT. Ø INT. Ø
Full Echo Pro 7002683 malleable 2,7 mm 21 cm 1,5 mm 0,5 mm yes 10 /box
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CCD CATALOG 2016
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ART
Frydman Ultrasoft EchoIdeal for those who are looking for an ultrasoft catheter
The use of ultrasoft catheters reduces the risk ofinducing uterine contractions.
To facilitate the catheter insertion, the rigidintroduction sheath will help passing the cervix.
The Frydman UItrasoft Echo catheter has anechogenic ring at its tip, to control the catheterposition under ultrasound guidance. The catheteris supported by a metalic stylet in its proximalsection to facilitate its handling.
DESIGNATION ORDERREFERENCE
INSERTION SHEATH CATHETERECHOGENIC PACKAGING
TYPE EXT. Ø LENGTH EXT. Ø INT. Ø
FrydmanUltrasoft Echo 7002666 straight 2,2 mm 21,5 cm 1,55 mm 0,7 mm yes 10 /box
EMBRYO TRANSFERSets for embryo transfer
Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ART
TDT setUltra-thin transfer catheter
The TDT set is composed of:
• an insertion sheath with flexible tip and twomarkings at 5,5 and 6,5 cm ;
• a malleable metalic stylet that can be used to shapethe sheath to adapt it to the cervical profile of thepatient, in order to facilitate the insertion of thesheath ;
• a ultra-thin transfer catheter supported in itsproximal section to facilitate its manipulation. Whenthe catheter is inserted through the sheath, it exceeds2.5 cm from the sheath.
DESIGNATION ORDERREFERENCE
ACCESS SHEATH CATHETERECHOGENIC PACKAGING
TYPE EXT. Ø LENGTH EXT. Ø INT. Ø
TDT set 7002634 straight 2,2 mm 20,5 cm 1 mm 0,55 mm no 10 /box
EMBRYO TRANSFERSets for embryo transfer
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CCD CATALOGUE 2016
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ART
Frydman Memory The basic malleable catheter
1-piece catheter to transfer embryos with a minimum ofmanipulations.
The malleable catheter can be curved to adapts itsshape according to the cervical profile, to pass verynarrow or cryptic cervixes.
DÉNOMINATIONRÉFÉRENCE
POURCOMMANDE
TYPE LENGTH EXT. Ø INT. Ø ECHOGENIC PACKAGING
FrydmanMemory 7002735 malleable 18 cm 2,1 mm 0,7 mm no 10 /box
EMBRYO TRANSFER1-piece catheters
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
2. ART
Frydman ClassicThe basics for embryo transfer
1-piece catheter, for embryo transfer with aminimum of manipulations.
Frydman Classic : the basic catheter, with a softtip, for normal cervix.
DESIGNATION ORDERREFERENCE TYPE LENGTH EXT. Ø INT. Ø ECHOGENIC PACKAGING
FrydmanClassic 7002630 straight 18 cm 1,6 mm 1,1 mm no 25 /box
EMBRYO TRANSFER1-piece catheters
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3.Antenatal screening
3 Antenatal screening
Because antenatal screening is already a difficultmoment for the patient, Laboratoire CCD offers highquality devices to the gynecologists to help themrealise quality samplings and facilitate the procedure.
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3. ANTENATAL SCREENINGAMNIOCENTESIS
Needles for amniocentesis and cordocentesis
A reinforced echogenicity for a better control of the procedure
Needles with a sandblasted distal tip to reinforceits echogenic features. The stylet increases the needle rigidity tofacilitate its insertion and positioning.
This needle is designed for trans-abdominalsampling of amniotic fluid and fetal blood cord.
DESIGNATION ORDERREFERENCE LENGTH EXT. Ø COLOUR PACKAGING
Needle for amnio/cordocentesis
7002610 10 cm
0,9 mmG20
l yellow
25 /box7002599 12 cm l blue
7002609 15 cm l yellow
7004836 * 18 cm l blue
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Class IIa medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
* Will be available during the second semester of 2016.
CHORIONIC VILLUS SAMPLING
CVS setSafe chorionic villus sampling
Set with two coaxial echogenic needles for optimaltrans-abdominal CVS procedure under ultrasoundguidance.
The guide needle is fitted with a removable obturatingstylet closely adjusted to the needle’s bevel to avoidtissue coring when perforating the abdomen.
The fine biopsy needle for sample collection has 2 greenrings on its base for easy identification and handling.After removing the stylet, the fine biopsy needle iseasily slid through the guide needle to collect thespecimen.
DESIGNATION ORDERREFERENCE
GUIDE NEEDLE FINE BIOPSY NEEDLEPACKAGING
LENGTH INT. Ø EXT. Ø LENGTH INT. Ø EXT. Ø
CVS set 7002611 15 cm 1 mm 1,25 mm G 18 18,5 cm 0,6 mm 0,6 mm G 21 10 /box
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Class IIa medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
3. ANTENATAL SCREENING
3. EXAMENS PRéNATAUXBIOPSIE dU TROPHOBLASTE
Blache needleSimple needle with trocart
The Blache needle for echoguided transabdominalCVS procedure has a short beveled echogenicneedle with a lateral eye at its tip.
It is fitted with a triangular tip trocar for tissueperforation.
DESIGNATION ORDERREFERENCE
TOTALLENGTH INT. Ø EXT. Ø PACKAGING
Blache needle 7002601 11 cm 1,05 mm 1,3 mm G18 10 /box
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Class IIa medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
CHORIONIC VILLUS SAMPLING3. ANTENATAL SCREENING
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
ACCESSORIES
ABC systemSet for continuous aspiration
Puncture system for continuous aspiration, madeof a 20 mL syringe with stopper and an extensionline with a clamp.
It can be used together with the amniocentesisneedles or CVS needles, to avoid risks of movingthe needle’s tip when pulling back the syringeplunger.
DESIGNATION ORDERREFERENCE
TUBINGS SYRINGEPACKAGING
LENGTH CONNEXIONS VOLUME CONNEXIONS
ABC system 7002709 5 cm
FemaleLuer-lock
+ rotative maleLuer-lock
20 ml MaleLuer-lock 10 /box
3. ANTENATAL SCREENING
4.Obstetrics
4 Obstetrics
Because it is important to count on the devices used inthe case of difficult deliveries, Laboratoire CCD offers ahigh quality device for amniotic membrane perforation:the Amniopic.
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4. OBSTETRICSMEMBRANE PERFORATION
AmniopicSafe amniotic membrane perforation
The Amniopic is a device for amniotic membraneperforation, slightly curved to follow the normalpelvic curve.
The external part of its distal tip is rounded andthe hook is shaped to avoid lesions to thesurrounding tissues during the insertion.
DESIGNATION ORDERREFERENCE LENGTH PACKAGING
Amniopic 7002742 25 cm 25 /box
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Sterile class I medical device.Manufacturer : Laboratoire CCD - CE0459.Read instructions for use.Use before expiry date written on the packaging. Do not use if the packaging or primary packaging has been damaged.
Index of references
DESIGNATION ORDER REFERENCE PAGE
ABC system 7002709 40
Amniocentesis needle 10 cm 7002610 37
Amniocentesis needle 12 cm 7002599 37
Amniocentesis needle 15 cm 7002609 37
Amniocentesis needle 18 cm 7004836 37
Amniopic 7002742 43
Blache needle 7002601 39
Bloc connector 7002704 17
CVS set 7002611 38
Dilatator large model 7002711 5
Dilatator small model 7002710 5
Duo-Brush 7002604 8
Duo-Brush non sterile 7002605 8
Endobrush 7002608 10
Endocyte 7002586 11
Frydman Classic 4.5 7002630 33
Frydman Memory 7002735 32
Frydman Ultrasoft Echo 7002666 30
Frydman Ultrasoft 7002665 30
Full Echo Pro 7002683 29
Hysterometer CH 10 7002736 4
Hysterometer CH 12 7002737 4
Hysterometer CH 14 7002738 4
IUI catheter Genitor 7002725 23
IUI catheter malleable 7002728 23
IUI catheter standard 7002726 23
IVF & IUI syringe 7002655 22
OPS ART of CCD with stopcock 7002640 24
OPS ART of CCD without stopcock 7002639 24
Index of references
DESIGNATION ORDER REFERENCE PAGE
OPS Classic with stopcock 7002625 25
OPS Classic without stopcock 7002624 25
OPS 15 mL collection vial 7002761 27
Ovo ART of CCD needle 7002645 26
Ovo Classic needle 7002691 26
Pipelle de Cornier 7002588 12
Pipelle de Cornier Mark II 7002716 12
Pipelle H 7002606 13
Rudigoz catheter 7002690 15
Scrinet 3 mm - non sterile 7002593 9
Scrinet 3 mm - sterile 7002591 9
Scrinet 5 mm - non sterile 7002594 9
Scrinet 5 mm - sterile 7002592 9
Seren ET 7004319 28
Sift syringe 7002705 17
Siscone 7002620 14
Sliding rigister 20 mm 7002694 16
Sliding rigister 25 mm 7002695 16
Sliding rigister 30 mm 7002696 16
Sliding rigister 35 mm 7002697 16
Speculum - Collin type 7002702 3
Speculum - Cusco type 16 mm 7004684 3
Speculum - Cusco type 24 mm 7004685 3
Speculum - Cusco type 30 mm 7004686 3
Sperm collection vial 7002614 21
Spirette 7002590 21
TDT set 7002634 31
Ultrasound probe cover 7004820 7
Lookup tableold references➞ new references
CE MARKINGREFERENCE
ORDERREFERENCE DESIGNATION
1102000 7002586 Endocyte
1103000 7002588 Pipelle de Cornier
1106000 7002590 Spirette
1107030 7002591 Scrinet 3 mm - sterile
1107055 7002592 Scrinet 5 mm - sterile
1107530 7002593 Scrinet 3 mm - non sterile
1107555 7002594 Scrinet 5 mm - non sterile
1110600 7002599 Amniocentesis needle 12 cm
1110800 7002601 Blache needle
1112101 7002604 Duo-Brush
1112201 7002605 Duo-Brush - non sterile
1112301 7002606 Pipelle H
1113000 7002608 Endobrush
1119615 7002609 Amniocentesis needle 15 cm
1140701 7002610 Amniocentesis needle 10 cm
1141201 7002611 CVS set
1206000 7002614 Sperm collection vial
1222001 7002620 Siscone
1301020 7002624 OPS Classic without stopcock
1301021 7002625 OPS Classic with stopcock
1306045 7002630 Frydman Classic 4.5
1308000 7002634 TDT set
1313000 7002761 OPS 15 mL collection vial
1313101 7002639 OPS ART of CCD without stopcock
1313201 7002640 OPS ART of CCD with stopcock
CE MARKINGREFERENCE
ORDERREFERENCE DESIGNATION
1313701 7002645 Ovo ART of CCD needle
1323101 7002655 IVF & IUI syringe
1324301 7002666 Frydman Ultrasoft Echo
1326801 7002683 Full Echo Pro
1402000 7002690 Rudigoz catheter
1403001 7002691 Ovo Classic needle
1404020 7002694 Sliding rigister 20 mm
1404025 7002695 Sliding rigister 25 mm
1404030 7002696 Sliding rigister 30 mm
1404035 7002697 Sliding rigister 35 mm
1506000 7002702 Collin-type speculum
1507000 7002704 Bloc connector
1509000 7002705 Sift syringe
1604000 7002709 ABC system
1605000 7002710 Dilator small model
1605001 7002711 Dilator large model
111020100 7002716 Pipelle de Cornier Mark II
120400M 7002725 IUI catheter Genitor
120400S 7002726 IUI catheter standard
12040MF 7002728 IUI catheter malleable
130MF45 7002735 Frydman Memory
1502S10 7002736 Hysterometer CH 10
1502S12 7002737 Hysterometer CH 12
1502S14 7002738 Hysterometer CH 14
16004PO 7002742 Amniopic
Lookup tableold references➞ new references
Lookup tablenew references ➞ old references
ORDERREFERENCE
CE MARKINGREFERENCE DESIGNATION
7002586 1102000 Endocyte
7002588 1103000 Pipelle de Cornier
7002590 1106000 Spirette
7002591 1107030 Scrinet 3 mm - sterile
7002592 1107055 Scrinet 5 mm - sterile
7002593 1107530 Scrinet 3 mm - non sterile
7002594 1107555 Scrinet 5 mm - non sterile
7002599 1110600 Amniocentesis needle 12 cm
7002601 1110800 Blache needle
7002604 1112101 Duo-Brush
7002605 1112201 Duo-Brush - non sterile
7002606 1112301 Pipelle H
7002608 1113000 Endobrush
7002609 1119615 Amniocentesis needle 15 cm
7002610 1140701 Amniocentesis needle 10 cm
7002611 1141201 CVS set
7002614 1206000 Sperm collection vial
7002620 1222001 Siscone
7002624 1301020 OPS Classic without stopcock
7002625 1301021 OPS Classic with stopcock
7002630 1306045 Frydman Classic 4.5
7002634 1308000 TDT set
7002639 1313101 OPS ART of CCD without stopcock
7002640 1313201 OPS ART of CCD with stopcock
7002645 1313701 Ovo ART of CCD needle
ORDERREFERENCE
CE MARKINGREFERENCE DESIGNATION
7002655 1323101 IVF & IUI syringe
7002666 1324301 Frydman Ultrasoft Echo
7002683 1326801 Full Echo Pro
7002690 1402000 Rudigoz catheter
7002691 1403001 Ovo Classic needle
7002694 1404020 Sliding rigister 20 mm
7002695 1404025 Sliding rigister 25 mm
7002696 1404030 Sliding rigister 30 mm
7002697 1404035 Sliding rigister 35 mm
7002702 1506000 Collin-type speculum
7002704 1507000 Bloc connector
7002705 1509000 Sift syringe
7002709 1604000 ABC system
7002710 1605000 Dilator - small model
7002711 1605001 Dilator - large model
7002716 111020100 Pipelle de Cornier Mark II
7002725 120400M IUI catheter Genitor
7002726 120400S IUI catheter standard
7002728 12040MF IUI catheter malleable
7002735 130MF45 Frydman Memory
7002736 1502S10 Hysterometer CH 10
7002737 1502S12 Hysterometer CH 12
7002738 1502S14 Hysterometer CH 14
7002742 16004PO Amniopic
7002761 1313000 OPS 15 mL collection vial
Lookup tablenew references ➞ old references
Notes
2016
/01
- SY
SMA
GE
2394
for lifeYour partner
Laboratoire CCD 48 rue des Petites Ecuries – 75010 Paris – France
Export department Phone + 33 (0) 3 44 26 89 51 – Fax + 33 (0) 3 44 26 57 42
www.ccd-lab.com [email protected]