34
See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017
FORM FDA - 3356 (5/14)
DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
2875 Northwoods Pkwy
Lifelink of Georgia (Atlanta Office)
800-544-6667 EXTa. PHONE
6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code)
a. PHONE EXT800-544-6667
PART I - ESTABLISHMENT INFORMATION PART II - PRODUCT INFORMATION
4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code)
Norcross, Georgia 30071
9. REPORTING OFFICIAL'S SIGNATURE
c. TITLE V.P./ Exec. Director
a. TYPED NAME
d. DATE
Kathy Lilly
5. ENTER CORRECTIONS TO ITEM 4
7. ENTER CORRECTIONS TO ITEM 6
VALIDATION--FOR FDA USE ONLY
3. OTHER FDA REGISTRATIONS
a. BLOOD FDA 2830
b. DEVICES FDA 2891
c. DRUG FDA 2656
NO.
NO.
NO.
10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps
a. Bone
b. Cartilage
c. Cornea
d. Dura Mater
VALIDATED BY FDA:02-DEC-2015DISTRICT: AtlantaPRINTED BY FDA:16-DEC-2015ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)(See reverse side for instructions)
8. U.S. AGENT
b. E-MAIL [email protected]
a. E-MAIL
b. PHONE
3003474667FEI:
1. REGISTRATION NUMBER 2. REASON FOR SUBMISSIONa. INITIAL REGISTRATION / LISTING
c. CHANGE IN INFORMATION
b. ANNUAL REGISTRATION / LISTINGX
01-DEC-2015
s.
t.
u.
v.
1
(FDA Establishment Identifier)
d. INACTIVE
Kathy LillyAttn: Kathy Lilly2875 Northwoods PkwyNorcross, Georgia 30071
b. SATELLITE RECOVERY ESTABLISHMENT
c. TESTING FOR MICRO-ORGANISMS ONLY
Establishment Functions
Types of HCT / Ps
f. Fascia
g. Heart Valve
h. Ligament
e. EmbryoSIPDirectedAnonymous
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
i. OocyteSIPDirectedAnonymous
j. Pericardium
l. Sclera
n. Skin
p. Tendon
r. Vascular Graft
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
11. HC
T/P
s D
ES
CR
IBE
D IN
21 C
FR
1271.10
12. HC
T/P
s R
EG
UL
AT
ED
AS
M
ED
ICA
L D
EV
ICE
S
13. HC
T/P
s R
EG
UL
AT
ED
AS
D
RU
GS
OR
B
IOL
OG
ICA
L D
RU
GS
Recover Screen Test Package Process Store Label Distribute
14. PROPRIETARY NAME(S)
q. Umbilical Cord Blood
AutologousFamily RelatedAllogeneic
o. Somatic CellTherapyProducts
AutologousFamily RelatedAllogeneic
m. SemenSIPDirectedAnonymous
k. PeripheralBlood Stem
AutologousFamily RelatedAllogeneic
X
X
X
X
X
X
(MANUFACTURING ESTABLISHMENT FEI NO._________________
See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017
FORM FDA - 3356 (5/14)
DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
1739 South Orange Ave.
LifeLink Tissue Bank - Orlando
407-218-8783 EXTa. PHONE
6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code)
a. PHONE EXT813-886-8111 4325
PART I - ESTABLISHMENT INFORMATION PART II - PRODUCT INFORMATION
4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code)
Orlando, Florida 32806
9. REPORTING OFFICIAL'S SIGNATURE
c. TITLE VP, QA
a. TYPED NAME
d. DATE
Elizabeth S. Horn-Brinson, BS
5. ENTER CORRECTIONS TO ITEM 4
7. ENTER CORRECTIONS TO ITEM 6
VALIDATION--FOR FDA USE ONLY
3. OTHER FDA REGISTRATIONS
a. BLOOD FDA 2830
b. DEVICES FDA 2891
c. DRUG FDA 2656
NO.
NO.
NO.
10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps
a. Bone
b. Cartilage
c. Cornea
d. Dura Mater
VALIDATED BY FDA:21-NOV-2015DISTRICT: FloridaPRINTED BY FDA:03-DEC-2015ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)(See reverse side for instructions)
8. U.S. AGENT
b. E-MAIL [email protected]
a. E-MAIL
b. PHONE
3007197601FEI:
1. REGISTRATION NUMBER 2. REASON FOR SUBMISSIONa. INITIAL REGISTRATION / LISTING
c. CHANGE IN INFORMATION
b. ANNUAL REGISTRATION / LISTINGX
20-NOV-2015
s.
t.
u.
v.
1
(FDA Establishment Identifier)
d. INACTIVE
LifeLink Tissue BankAttn: Elizabeth S. Horn-Brinson, BS9661 Delaney Creek BoulevardTampa, Florida 33619
b. SATELLITE RECOVERY ESTABLISHMENT
c. TESTING FOR MICRO-ORGANISMS ONLY
Establishment Functions
Types of HCT / Ps
f. Fascia
g. Heart Valve
h. Ligament
e. EmbryoSIPDirectedAnonymous
X
X
X
X
X
X
X
X
X
X
X
X
i. OocyteSIPDirectedAnonymous
j. Pericardium
l. Sclera
n. Skin
p. Tendon
r. Vascular Graft
XX X
11. HC
T/P
s D
ES
CR
IBE
D IN
21 C
FR
1271.10
12. HC
T/P
s R
EG
UL
AT
ED
AS
M
ED
ICA
L D
EV
ICE
S
13. HC
T/P
s R
EG
UL
AT
ED
AS
D
RU
GS
OR
B
IOL
OG
ICA
L D
RU
GS
Recover Screen Test Package Process Store Label Distribute
14. PROPRIETARY NAME(S)
q. Umbilical Cord Blood
AutologousFamily RelatedAllogeneic
o. Somatic CellTherapyProducts
AutologousFamily RelatedAllogeneic
m. SemenSIPDirectedAnonymous
k. PeripheralBlood Stem
AutologousFamily RelatedAllogeneic
X
X
X
X
X
LifeGraft, TruArc, LifeFlex
(MANUFACTURING ESTABLISHMENT FEI NO._________________
See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017
FORM FDA - 3356 (5/14)
DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
Daimler-Chrysler Bldg./Metro Office Park
Lifelink of Puerto Rico
Street 1 # 1, Suite 100
800-558-0977 EXTa. PHONE
6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code)
a. PHONE EXT813-886-8111 4325
PART I - ESTABLISHMENT INFORMATION PART II - PRODUCT INFORMATION
4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code)
Guaynabo, Puerto Rico 00968-1705
9. REPORTING OFFICIAL'S SIGNATURE
c. TITLE VP, QA
a. TYPED NAME
d. DATE
Elizabeth S. Horn-Brinson
5. ENTER CORRECTIONS TO ITEM 4
7. ENTER CORRECTIONS TO ITEM 6
VALIDATION--FOR FDA USE ONLY
3. OTHER FDA REGISTRATIONS
a. BLOOD FDA 2830
b. DEVICES FDA 2891
c. DRUG FDA 2656
NO.
NO.
NO.
10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps
a. Bone
b. Cartilage
c. Cornea
d. Dura Mater
VALIDATED BY FDA:21-NOV-2015DISTRICT: San JuanPRINTED BY FDA:03-DEC-2015ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)(See reverse side for instructions)
8. U.S. AGENT
b. E-MAIL [email protected]
a. E-MAIL
b. PHONE
3001238470FEI:
1. REGISTRATION NUMBER 2. REASON FOR SUBMISSIONa. INITIAL REGISTRATION / LISTING
c. CHANGE IN INFORMATION
b. ANNUAL REGISTRATION / LISTINGX
20-NOV-2015
s.
t.
u.
v.
1
(FDA Establishment Identifier)
d. INACTIVE
LifeLink Tissue BankAttn: Elizabeth S. Horn-Brinson9661 Delaney Creek BoulevardTampa, Florida 33619
b. SATELLITE RECOVERY ESTABLISHMENT
c. TESTING FOR MICRO-ORGANISMS ONLY
Establishment Functions
Types of HCT / Ps
f. Fascia
g. Heart Valve
h. Ligament
e. EmbryoSIPDirectedAnonymous
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
i. OocyteSIPDirectedAnonymous
j. Pericardium
l. Sclera
n. Skin
p. Tendon
r. Vascular Graft
X
X
X
X
X
X
X
X
X
11. HC
T/P
s D
ES
CR
IBE
D IN
21 C
FR
1271.10
12. HC
T/P
s R
EG
UL
AT
ED
AS
M
ED
ICA
L D
EV
ICE
S
13. HC
T/P
s R
EG
UL
AT
ED
AS
D
RU
GS
OR
B
IOL
OG
ICA
L D
RU
GS
Recover Screen Test Package Process Store Label Distribute
14. PROPRIETARY NAME(S)
q. Umbilical Cord Blood
AutologousFamily RelatedAllogeneic
o. Somatic CellTherapyProducts
AutologousFamily RelatedAllogeneic
m. SemenSIPDirectedAnonymous
k. PeripheralBlood Stem
AutologousFamily RelatedAllogeneic
(MANUFACTURING ESTABLISHMENT FEI NO._________________
View current license information at: Floridahealthfinder.gov
View current license information at: Floridahealthfinder.gov LICENSE #: 163
CERTIFICATE #: 1203
State of Florida AGENCY FOR HEALTH CARE ADMINISTRATION
DIVISION OF HEALTH QUALITY ASSURANCE
Tissue Bank Licensed
This is to confirm that Lifelink Foundation Inc has complied with the requirements of the State of Florida, Agency for Health Care
Administration, for certification as authorized by Florida Statutes 765.542 and is to operate the following:
LIFELINK TISSUE BANK
9661 Delaney Creek Blvd
Tampa, FL 33619
Authorized Services: recover, process, distribute and storage tissues
EFFECTIVE DATE: 08/17/2016
EXPIRATION DATE: 08/16/2018 Deputy Secretary, Division of Health Quality Assurance
View current license information at: Floridahealthfinder.gov
View current license information at: Floridahealthfinder.gov LICENSE #: 155
CERTIFICATE #: 1142
State of Florida AGENCY FOR HEALTH CARE ADMINISTRATION
DIVISION OF HEALTH QUALITY ASSURANCE
Tissue Bank Licensed
This is to confirm that Lifelink Foundation Inc has complied with the requirements of the State of Florida, Agency for Health Care
Administration, for certification as authorized by Florida Statutes 765.542 and is to operate the following:
LIFELINK TISSUE BANK - ORLANDO
1739 S Orange Ave
Orlando, FL 32806
Authorized Services: distribute and storage tissues
EFFECTIVE DATE: 03/09/2016
EXPIRATION DATE: 03/08/2018 Deputy Secretary, Division of Health Quality Assurance
See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017
FORM FDA - 3356 (5/14)
DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
1125 W. Pinnacle Peak Rd
Pinnacle Transplant Technologies, LLC
Bldg 2
623-277-5400 EXTa. PHONE 405
6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code)
a. PHONE EXT623-277-5400 405
PART I - ESTABLISHMENT INFORMATION PART II - PRODUCT INFORMATION
4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code)
Phoenix, Arizona 85027
9. REPORTING OFFICIAL'S SIGNATURE
c. TITLE President/Executive Director
a. TYPED NAME
d. DATE
Gabriel R. Hyams, MBA
5. ENTER CORRECTIONS TO ITEM 4
7. ENTER CORRECTIONS TO ITEM 6
VALIDATION--FOR FDA USE ONLY
3. OTHER FDA REGISTRATIONS
a. BLOOD FDA 2830
b. DEVICES FDA 2891
c. DRUG FDA 2656
NO.
NO.
NO.
10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps
Amniotic Membrane
Amniotic Fluid
a. Bone
b. Cartilage
c. Cornea
d. Dura Mater
VALIDATED BY FDA:17-DEC-2015DISTRICT: Los AngelesPRINTED BY FDA:22-JAN-2016ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)(See reverse side for instructions)
8. U.S. AGENT
b. E-MAIL [email protected]
a. E-MAIL
b. PHONE
3008927553FEI:
1. REGISTRATION NUMBER 2. REASON FOR SUBMISSIONa. INITIAL REGISTRATION / LISTING
c. CHANGE IN INFORMATION
b. ANNUAL REGISTRATION / LISTINGX
16-DEC-2015
s.
t.
u.
v.
1
(FDA Establishment Identifier)
d. INACTIVE
Pinnacle Transplant Technologies, LLCAttn: Gabriel R. Hyams, MBA1125 W. Pinnacle Peak RdBldg 2Phoenix, Arizona 85027
b. SATELLITE RECOVERY ESTABLISHMENT
c. TESTING FOR MICRO-ORGANISMS ONLY
Establishment Functions
Types of HCT / Ps
f. Fascia
g. Heart Valve
h. Ligament
e. EmbryoSIPDirectedAnonymous
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
i. OocyteSIPDirectedAnonymous
j. Pericardium
l. Sclera
n. Skin
p. Tendon
r. Vascular Graft
X
X
X
X
X
X
X
X
X
X
X
X
X
X
11. HC
T/P
s D
ES
CR
IBE
D IN
21 C
FR
1271.10
12. HC
T/P
s R
EG
UL
AT
ED
AS
M
ED
ICA
L D
EV
ICE
S
13. HC
T/P
s R
EG
UL
AT
ED
AS
D
RU
GS
OR
B
IOL
OG
ICA
L D
RU
GS
Recover Screen Test Package Process Store Label Distribute
14. PROPRIETARY NAME(S)
q. Umbilical Cord Blood
AutologousFamily RelatedAllogeneic
X
X
o. Somatic CellTherapyProducts
AutologousFamily RelatedAllogeneic
m. SemenSIPDirectedAnonymous
k. PeripheralBlood Stem
AutologousFamily RelatedAllogeneic
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
AUXANO (tm) Bone Putty, Apex DBM Putty
See Additonal Info Section For TM
(MANUFACTURING ESTABLISHMENT FEI NO._________________
*** See full text on next page
See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017
FORM FDA - 3356 (5/14)
DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATIONESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)(See reverse side for instructions)
ADDITIONAL INFORMATION:
3008927553FEI:
1. REGISTRATION NUMBER
PalinGen Membrane PalinGen HydroMembrane PalinGen KardiaMembrane PalinGen XPlus PalinGen XPlus HydroMembrane PalinGen Kardia XPlus XWrap ECM XWrap Dry XWrap HydroPlus AlloShield Dry ASGBarrier-Wet SXBarrier Nanofactor Membrane Gryphon Amnio Hydroflex PalinGen Flow PalinGen SportFlow PalinGen KardiaFlow ProMatrX ACF Flograft Allogen ASGFluid Nanofactor Flow cell-ECT SXFluid Amnioflex Gryphon Amnio Flow
Page: 2
2
(FDA Establishment Identifier)
Amniotic Membrane
See Additional Info Secton for Trade NamesProprietary Name(s):
DELAWARE HEALTH AND SOCIAL SERVICES
DIVISION OF PUBLIC HEALTH
Thursday, March 03, 2016
Joanne Ventura Pinnacle Transplant Technologies, LLC Phoenix, AZ 85027
Dear Joanne Ventura,
This letter confirms that Pinnacle Transplant Technologies, LLC is registered with the Delaware
Tissue Bank until April 30, 2017.
Thank you for notifying the Bureau of Communicable Diseases office in a timely manner of any
changes to the information contained in the registration form. Please continue to keep contact
information current to ensure timely delivery of updates and notifications.
If you have any questions, please contact me at the number below, or via my e-mail.
Best regards,
Jon Hildick-Smith
Delaware’s Division of Public Health
Bureau of Infectious Disease Prevention & Control
Ph. 302-744-1056 Fax 302-739-2549
View current license information at: Floridahealthfinder.gov
View current license information at: Floridahealthfinder.gov LICENSE #: 184
CERTIFICATE #: 1163
State of Florida AGENCY FOR HEALTH CARE ADMINISTRATION
DIVISION OF HEALTH QUALITY ASSURANCE
Tissue Bank Licensed
This is to confirm that Pinnacle Transplant Technologies LLC has complied with the requirements of the State of Florida, Agency for Health Care
Administration, for certification as authorized by Florida Statutes 765.542 and is to operate the following:
PINNACLE TRANSPLANT TECHNOLOGIES LLC
1125 W Pinnacle Peak Rd
Bldg 2
Phoenix, AZ 85027-1401
Authorized Services: distribute tissues
EFFECTIVE DATE: 01/24/2016
EXPIRATION DATE: 01/23/2018 Deputy Secretary, Division of Health Quality Assurance
