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See Instructions for OMB Statement.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
(FDA Establishment Identifier)
ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
FEI:
Label
Distribute
c. DRUG FDA 2656
NO.
X
X
X
X
X
X
X
X
X
X
X
f. Fascia
X
X
X
X
X
X
g. Heart Valve
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Types of HCT / Ps
4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and
post office code)
Lifelink of Georgia (Atlanta Office)
2875 Northwoods Pkwy
Norcross, Georgia 30071
Recover
Screen
a. Bone
X
b. Cartilage
Test
Package
Process
c. Cornea
d. Dura Mater
e. Embryo
EXT
a. PHONE 800-544-6667
b.
SATELLITE RECOVERY ESTABLISHMENT
(MANUFACTURING ESTABLISHMENT FEI NO._________________
c.
TESTING FOR MICRO-ORGANISMS ONLY
5. ENTER CORRECTIONS TO ITEM 4
SIP
Directed
Anonymous
h. Ligament
6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable,
number and street, city, state, country, and post office code)
Kathy Lilly
Attn: Kathy Lilly
2875 Northwoods Pkwy
Norcross, Georgia 30071
i. Oocyte
SIP
Directed
Anonymous
j. Pericardium
k. Peripheral
Blood Stem
X
Autologous
Family Related
Allogeneic
l. Sclera
a. PHONE 800-544-6667
7. ENTER CORRECTIONS TO ITEM 6
m. Semen
EXT
b. PHONE
n. Skin
o. Somatic Cell
Therapy
Products
8. U.S. AGENT
r. Vascular Graft
a. E-MAIL
9. REPORTING OFFICIAL'S SIGNATURE
s.
t.
a. TYPED NAME
FORM FDA - 3356 (5/14)
u.
d. DATE
01-DEC-2015
v.
X
Autologous
Family Related
Allogeneic
p. Tendon
q. Umbilical
Cord Blood
Kathy Lilly
b. E-MAIL [email protected]
c. TITLE V.P./ Exec. Director
SIP
Directed
Anonymous
X
X
X
X
Autologous
Family Related
Allogeneic
X
13. HCT/Ps
REGULATED AS
DRUGS OR
BIOLOGICAL DRUGS
Store
10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps
Establishment Functions
12. HCT/Ps
REGULATED AS
MEDICAL DEVICES
NO.
INACTIVE
11. HCT/Ps
DESCRIBED IN 21
CFR 1271.10
b. DEVICES FDA 2891
d.
X
PART II - PRODUCT INFORMATION
3. OTHER FDA REGISTRATIONS
NO.
c.
VALIDATION--FOR FDA USE ONLY
VALIDATED BY FDA:02-DEC-2015
ANNUAL REGISTRATION / LISTING DISTRICT: Atlanta
PRINTED BY FDA:16-DEC-2015
CHANGE IN INFORMATION
b.
3003474667
(See reverse side for instructions)
PART I - ESTABLISHMENT INFORMATION
a. BLOOD FDA 2830
FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017
2. REASON FOR SUBMISSION
a.
INITIAL REGISTRATION / LISTING
1. REGISTRATION NUMBER
14. PROPRIETARY
NAME(S)
1
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