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See
Inst
ruct
ions
for
OM
B S
tate
men
t. F
OR
M A
PP
RO
VE
D:O
MB
No.
0910
-054
3. E
xpira
tion
Dat
e: 3
/31/
2017
FOR
M F
DA
- 33
56 (5
/14)
DE
PA
RT
ME
NT
OF
HE
ALT
H A
ND
HU
MA
N S
ER
VIC
ES
PU
BLI
C H
EA
LTH
SE
RV
ICE
FO
OD
AN
D D
RU
G A
DM
INIS
TR
AT
ION
2900
Col
lege
Driv
e
Com
mun
ity B
lood
Cen
ter d
ba C
omm
unity
Tis
sue
Serv
ices
937-
222-
0228
EX
Ta.
PH
ON
E
6. M
AIL
ING
AD
DR
ESS
OF
REP
OR
TIN
G O
FFIC
IAL
(Inc
lude
inst
itutio
n na
me
if ap
plic
able
, n
umbe
r an
d st
reet
, city
, sta
te, c
ount
ry, a
nd p
ost o
ffice
cod
e)
a. P
HO
NE
EX
T93
7-46
1-34
5036
10
PAR
T I -
EST
AB
LISH
MEN
T IN
FOR
MA
TIO
NPA
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II-P
RO
DU
CT
INFO
RM
ATI
ON
4. P
HYS
ICA
L LO
CA
TIO
N(I
nclu
de le
gal n
ame,
num
ber
and
stre
et, c
ity, s
tate
, cou
ntry
, and
pos
t offi
ce c
ode)
Ket
terin
g, O
hio
454
20
9. R
EPO
RTI
NG
OFF
ICIA
L'S
SIG
NA
TUR
E
c. T
ITLE
CEO
a. T
YP
ED
NA
ME
d. D
AT
E
Dav
id M
. Sm
ith, M
D
5. E
NTE
R C
OR
REC
TIO
NS
TO IT
EM 4
7. E
NTE
R C
OR
REC
TIO
NS
TO IT
EM 6
VA
LID
AT
ION
--F
OR
FD
A U
SE
ON
LY
3. O
THER
FD
A R
EGIS
TRA
TIO
NS
a. B
LOO
D F
DA
283
0
b. D
EV
ICE
S F
DA
289
1
c. D
RU
G F
DA
265
6
NO
.
NO
.
NO
.
10.
ESTA
BLI
SHM
ENT
FUN
CTI
ON
S A
ND
TYP
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/ Ps
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Per
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al M
embr
ane
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a
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ura
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ENT
REG
ISTR
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ON
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D L
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NG
FO
R H
UM
AN
CEL
LS, T
ISSU
ES,
AN
D C
ELLU
LAR
AN
D T
ISSU
E-B
ASE
D P
RO
DU
CTS
(HC
T/Ps
)(S
ee r
ever
se s
ide
for
inst
ruct
ions
)
8. U
.S. A
GEN
T
b. E
-MA
ILds
mith
@cb
ccts
.org
a. E
-MA
IL
b. P
HO
NE
3008
8081
82FE
I:
1. R
EGIS
TRA
TIO
N N
UM
BER
2. R
EASO
N F
OR
SU
BM
ISSI
ON
a.
INIT
IAL
RE
GIS
TR
AT
ION
/ LI
ST
ING
c.
CH
AN
GE
IN IN
FO
RM
AT
ION
b.
AN
NU
AL
RE
GIS
TR
AT
ION
/ LI
ST
ING
X
16-N
OV
-201
5
s. t. u. v.
1
(FD
A E
stab
lishm
ent I
dent
ifier
)
d.
INA
CT
IVE
Com
mun
ity B
lood
Cen
ter d
ba C
omm
unity
Tis
sue
Serv
ices
Attn
: Dav
id M
. Sm
ith, M
D34
9 So
uth
Mai
n St
reet
Day
ton,
Ohi
o 4
5402
-271
5
b.
S
AT
ELL
ITE
RE
CO
VE
RY
ES
TA
BLI
SH
ME
NT
c.
T
ES
TIN
G F
OR
MIC
RO
-OR
GA
NIS
MS
ON
LY
Esta
blis
hmen
t Fun
ctio
ns
Type
s of
HC
T / P
s
f. F
asci
a
g. H
eart
Val
ve
h. L
igam
ent
e. E
mbr
yoS
IPD
irect
edA
nony
mou
s
X X
X X
X X
X X
X X
X X
X X
X X
X X
X X
i. O
ocyt
eS
IPD
irect
edA
nony
mou
s
Der
map
ure,
Tru
Skin
j. P
eric
ardi
um
l. S
cler
a
n. S
kin
p. T
endo
n
r. V
ascu
lar
Gra
ft
X X X
X X X
X X X
X X X
X X X
11. HCT/Ps DESCRIBED IN 21 CFR 1271.10
12. HCT/Ps REGULATED AS MEDICAL DEVICES
13. HCT/Ps REGULATED AS DRUGS OR BIOLOGICAL DRUGS
Rec
over
Scre
enTe
stPa
ckag
ePr
oces
sSt
ore
Labe
lD
istr
ibut
e
14. P
RO
PRIE
TAR
Y N
AM
E(S)
q. U
mbi
lical
Cor
d B
lood
A
utol
ogou
sF
amily
Rel
ated
Allo
gene
ic
X X
o. S
omat
ic C
ell
T
hera
py
Pro
duct
s
Aut
olog
ous
Fam
ily R
elat
edA
lloge
neic
m. S
emen
SIP
Dire
cted
Ano
nym
ous
k. P
erip
hera
l
Blo
od S
tem
Aut
olog
ous
Fam
ily R
elat
edA
lloge
neic
XX
X XX
X XX XX X X X X
Allo
mem
(MA
NU
FA
CT
UR
ING
ES
TA
BLI
SH
ME
NT
FE
I NO
.___
____
____
____
__
***
See
full
text
on
next
pag
e
See
Inst
ruct
ions
for
OM
B S
tate
men
t. F
OR
M A
PP
RO
VE
D:O
MB
No.
0910
-054
3. E
xpira
tion
Dat
e: 3
/31/
2017
FOR
M F
DA
- 33
56 (5
/14)
DE
PA
RT
ME
NT
OF
HE
ALT
H A
ND
HU
MA
N S
ER
VIC
ES
PU
BLI
C H
EA
LTH
SE
RV
ICE
FO
OD
AN
D D
RU
G A
DM
INIS
TR
AT
ION
ESTA
BLI
SHM
ENT
REG
ISTR
ATI
ON
AN
D L
ISTI
NG
FO
R H
UM
AN
CEL
LS, T
ISSU
ES,
AN
D C
ELLU
LAR
AN
D T
ISSU
E-B
ASE
D P
RO
DU
CTS
(HC
T/Ps
)(S
ee r
ever
se s
ide
for
inst
ruct
ions
)
AD
DIT
ION
AL
INFO
RM
ATI
ON
:
3008
8081
82FE
I:
1. R
EGIS
TRA
TIO
N N
UM
BER
Page
: 2
2
(FD
A E
stab
lishm
ent I
dent
ifier
)
a. B
one
Max
xeus
, Rap
tos,
Allo
sorb
, Ora
gen,
Cre
os, O
stek
orPr
oprie
tary
Nam
e(s)
:
See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 613012020 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION--FOR FDA USE ONLY 1
PUBLIC HEALTH SERVICE (FDA Establishment Identifier) a. D INITIAL REGISTRATION I LISTING VALIDATED BY FDA:21-NOV-2017 FOOD AND DRUG ADMINISTRATION b. D ANNUAL REGISTRATION I LISTING DISTRICT: Dallas
ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3009234552 c. 00 CHANGE IN INFORMATION
PRINTED BY FDA:27-JAN-2018 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
(See reverse side for instructions) d. D INACTIVE PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION C'le o:::o- me ;a ""m mm!'J ::Oin 3. OTHER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs -o h>::O 8cns;:
Establishment Functions ::ta; 14. PROPRIETARY a. BLOOD FDA 2830 NO. :...m em"' NAME(S) e>e me ,... e Types of HCT I Ps z e )lo
b. DEVICES FDA 2891 NO. Recover Screen Test Package Process Store Label Distribute C'lln ::0 (I) m c: (I) G') en c. DRUG FDA 2656 NO.
4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code) a. Bone X X X X X X X *** See full text on next pag<
CellRight Technologies b. Cartilage
1808 Universal City Blvd c. Cornea Universal City, Texas 78148 d. Dura Mater
0SIP e. Embryo 0 Directed
a. PHONE 210-659-9353 EXT 0 Anonymous b.o SATELLITE RECOVERY ESTABLISHMENT
f. Fascia X X X X X X X D(MANUFACTURING ESTABLISHMENT FEI NO. c. TESTING FOR MICRO-ORGANISMS ONLY
5. ENTER CORRECTIONS TO ITEM 4 g. Heart Valve
h. Ligament X X X X X X X
0 SIP 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, i. Oocyte 0 Directed number and street, city, state, country, and post office code) 0 Anonymous
Cel!Right Technologies j . Pericardium X X X X X X X Attn: Robin M. Sullivan, DC, CTBS
1808 Universal City Blvd k. Peripheral 0 Autologous Universal City, Texas 78148 Blood Stem 0 Family Related
0AIIogeneic
I. Sclera
OSIP a. PHONE 210-659-9353 EXT m. Semen 0 Directed 7. ENTER CORRECTIONS TO ITEM 6 0 Anonymous
b. PHONE X X X X X X X MatrixiQ Dermis, DermaPure n. Skin
o. Somatic Cell 0 Autologous Therapy 0 Family Related Products 0
8. U.S. AGENT p. Tendon X X X X X X X
q. Umbilical Cord Blood 0 Family Related
0AIIogeneic
a. E-MAIL r. Vascular Graft
s. Amniotic Membrane X X X X X X X
. 07ff t. a. TYPED NAME Robin M. Sullivan, DC, CTBS b. E-MAIL [email protected]
u.
c. TITLE VP of Regulatory Affairs d. DATE 21-NOV-2017 v.
FORM FDA • 3356 (7/17)
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instructions)
ADDITIONAL INFORMATION:
Proprietary Name(s): a. Bone MatrixOI, FlexiT, Influx, MatrixCellect I 00 DBM
Putty, MatrixCellect I 00 DBM Crunch, ConCelltrate 100, Denta!Fix
FORM FDA - 3356 (7/17)
1. REGISTRATION NUMBER (FDA Establishment Identifier)
FEI: 3009234552
See Instructions for OMS Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 6/30/2020
Page:2