DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION See Instructions for OMB Statement FORM APPROVED: OMB No. 0910-0543. Expiration Date: 1/31/14 1 2. REASON FOR SUBMISSION VALIDATION--FOR FDA USE ONLY a. INITIAL REGISTRATION / LISTING VALIDATED BY FDA:19-NOV-2013 b. X ANNUAL REGISTRATION / LISTING DISTRICT: Los Angeles PRINTED BY FDA:09-DEC-2013 c. CHANGE IN INFORMATION 1. REGISTRATION NUMBER (FDA Establishment Identifier) ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) FEI: 3003421818 (See reverse side for instructions) d. NO. c. DRUG FDA 2656 NO. Types of HCT / Ps 4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code) UCSD Regional Tissue Bank X X X X X X X 3959 Ruffin Road Suite F San Diego, California 92123 X X X X X X X X X X X X X X X X X X X X X Recover Screen a. Bone X X b. Cartilage X f. Fascia g. Heart Valve Test Package Process Store Label c. Cornea d. Dura Mater e. Embryo EXT a. PHONE 619-521-1983 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) Lifesharing Community Organ and Tissue Donation Attn: Sylvain Cyr, BS, CTBS, ASQ-CMQ/OE 3465 Camino Del Rio South Suite 410 San Diego, California 92108 i. Oocyte X X X SIP Directed Anonymous j. Pericardium k. Peripheral Blood Stem X X Autologous Family Related Allogeneic l. Sclera a. PHONE 619-521-1983 7. ENTER CORRECTIONS TO ITEM 6 EXT 148 b. PHONE m. Semen n. Skin o. Somatic Cell Therapy Products 8. U.S. AGENT a. E-MAIL Sylvain Cyr, BS, CTBS, ASQ-CMQ/OE b. E-MAIL [email protected] d. DATE 18-NOV-2013 c. TITLE Tissue Bank Quality Manager a. TYPED NAME FORM FDA 3356 (11/11) Autologous Family Related Allogeneic p. Tendon q. Umbilical Cord Blood 9. REPORTING OFFICIAL'S SIGNATURE SIP Directed Anonymous Autologous Family Related Allogeneic r. Vascular Graft X X s. Nerve Tissue X X t. Adipose Tissue X X u. v. X X X X X 13. HCT/Ps REGULATED AS DRUGS OR BIOLOGICAL DRUGS b. DEVICES FDA 2891 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps Establishment Functions 12. HCT/Ps REGULATED AS MEDICAL DEVICES NO. Distribute PART II - PRODUCT INFORMATION 3. OTHER FDA REGISTRATIONS a. BLOOD FDA 2830 INACTIVE 11. HCT/Ps DESCRIBED IN 21 CFR 1271.10 PART I - ESTABLISHMENT INFORMATION 14. PROPRIETARY NAME(S)
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