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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