Establishment Registration And Listing For Human Cells Tissues And Cellular And Tissue Based Products

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See Instructions for PRA Statement. FORM APPROVED: OMB No. 0910-0543. Expiration Date: 3/31/2017
1. REGISTRATION NUMBER
2. REASON FOR SUBMISSION
VALIDATION – FOR FDA USE ONLY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FDA Establishment Identifier
INITIAL REGISTRATION/LISTING
a.
FOOD AND DRUG ADMINISTRATION
ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,
ANNUAL REGISTRATION/LISTING
b.
AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
FEI
c.
CHANGE IN INFORMATION
(See reverse side for instructions)
INACTIVE
d.
PART I – ESTABLISHMENT INFORMATION
PART II – HCT / P INFORMATION
3. OTHER FDA REGISTRATIONS
10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps
14. PROPRIETARY
Establishment Functions
a. BLOOD FDA 2830
NO.
NAMES
Types of HCT / Ps
b. DEVICE FDA 2891
NO.
Recover
Screen
Test
Package
Process
Store
Label
Distribute
c. DRUG FDA 2656
NO.
a. Bone
4. PHYSICAL LOCATION (Include legal name, number and street, city, state,
country, and post office code.)
b. Cartilage
c. Cornea
d. Dura Mater
SIP
e. Embryo
Directed
a. PHONE:
Anonymous
b.
SATELLITE RECOVERY ESTABLISHMENT
f. Fascia
(MANUFACTURING ESTABLISHMENT FEI NO.
)
c.
TESTING FOR MICRO-ORGANISMS ONLY
g. Heart Valve
5. ENTER CORRECTIONS TO ITEM 4
h. Ligament
SIP
i. Oocyte
Directed
Anonymous
6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if
j. Pericardium
applicable, number and street, city, state, country, and post office code.)
k. Peripheral
Autologous
Blood Stem
Family Related
Cells
Allogeneic
l. Sclera
SIP
m. Semen
Directed
Anonymous
a. PHONE:
n. Skin
7. ENTER CORRECTIONS TO ITEM 6
o. Somatic Cell
Autologous
Therapy
Family Related
Products
Allogeneic
p. Tendon
8. U.S. AGENT
q. Umbilical
Autologous
Cord Blood
Family Related
a. E-MAIL ADDRESS:
Stem Cells
Allogeneic
b. PHONE:
r. Vascular Graft
9. REPORTING OFFICIAL’S SIGNATURE
s.
t.
a. TYPED NAME:
u.
b. E-MAIL ADDRESS:
c. TITLE:
d. DATE:
v.
FORM FDA 3356 (5/14)
Page 1 of 2
EF
PSC Publishing Services (301) 443-6740

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