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:30-DEC-2013 b. X ANNUAL REGISTRATION / LISTING DISTRICT: Baltimore PRINTED BY FDA:27-JAN-2014 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: 3001236461 (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) TBI Baltimore/DC Medical Eye Bank of Maryland Recover Screen Test Process Store Label Distribute X X X X X X VisionGraft X X VisionGraft 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. Package 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) a. Bone b. Cartilage 1730 Twin Springs Road Suite 210 Baltimore, Maryland 21227 X c. Cornea d. Dura Mater e. Embryo EXT a. PHONE 410-752-2020 b. SATELLITE RECOVERY ESTABLISHMENT (MANUFACTURING ESTABLISHMENT FEI NO._________________ c. TESTING FOR MICRO-ORGANISMS ONLY SIP Directed Anonymous f. Fascia g. Heart Valve 5. ENTER CORRECTIONS TO ITEM 4 h. Ligament 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code) TBI / Tissue Banks International Attn: Petar Georgiev 2597 Kerner Blvd. San Rafael, California 94901 i. Oocyte SIP Directed Anonymous j. Pericardium k. Peripheral Blood Stem Autologous Family Related Allogeneic X l. Sclera a. PHONE 415-464-6110 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 (11/11) Autologous Family Related Allogeneic p. Tendon q. Umbilical Cord Blood Petar Georgiev b. E-MAIL [email protected] c. TITLE Associate, Regulatory Affairs SIP Directed Anonymous u. d. DATE 29-DEC-2013 v. Autologous Family Related Allogeneic X
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