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: b. 3001451643 c. (See reverse side for instructions) 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) Gift of Hope Organ and Tissue Donor Network 425 Spring Lake Drive Itasca, Illinois 60143 Recover Screen Test Package Process Store Label Distribute a. Bone X X X X b. Cartilage X X X X c. Cornea X X X X f. Fascia 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 X X X X r. Vascular Graft X X X X s. Adipose Tissue X X X X 13. HCT/Ps REGULATED AS DRUGS OR BIOLOGICAL DRUGS NO. 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps Establishment Functions 12. HCT/Ps REGULATED AS MEDICAL DEVICES b. DEVICES FDA 2891 INACTIVE 11. HCT/Ps DESCRIBED IN 21 CFR 1271.10 NO. VALIDATION--FOR FDA USE ONLY VALIDATED BY FDA:16-JUL-2014 ANNUAL REGISTRATION / LISTING DISTRICT: Chicago PRINTED BY FDA:18-JUL-2014 CHANGE IN INFORMATION PART II - PRODUCT INFORMATION 3. OTHER FDA REGISTRATIONS a. BLOOD FDA 2830 X d. PART I - ESTABLISHMENT INFORMATION FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017 2. REASON FOR SUBMISSION a. INITIAL REGISTRATION / LISTING 1. REGISTRATION NUMBER X X X X d. Dura Mater e. Embryo EXT a. PHONE 630-758-2600 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) Gift of Hope Organ and Tissue Donor Network Attn: Arnitha B. Lim, BSN, CTBS 425 Spring Lake Drive Itasca, Illinois 60143 i. Oocyte SIP Directed Anonymous j. Pericardium k. Peripheral Blood Stem Autologous Family Related Allogeneic l. Sclera a. PHONE 630.758.2715 7. ENTER CORRECTIONS TO ITEM 6 m. Semen EXT b. PHONE n. Skin o. Somatic Cell Therapy Products 8. U.S. AGENT a. E-MAIL 9. REPORTING OFFICIAL'S SIGNATURE t. Arnitha B. Lim, BSN, CTBS [email protected] Director of Tissue Program a. TYPED NAME c. TITLE FORM FDA - 3356 (5/14) Autologous Family Related Allogeneic p. Tendon q. Umbilical Cord Blood b. E-MAIL SIP Directed Anonymous u. d. DATE 15-JUL-2014 v. Autologous Family Related Allogeneic 14. PROPRIETARY NAME(S) 1 See Instructions for OMB Statement. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) 1. REGISTRATION NUMBER FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017 2 (FDA Establishment Identifier) FEI: 3001451643 (See reverse side for instructions) ADDITIONAL INFORMATION: Updating registration to add in Part II: cornea and sclera Proprietary Name(s): FORM FDA - 3356 (5/14) Page: 2