HANS BIOMED USA, Inc. 140 sylvan Ave Suite #4 Englewood Cliffs, NJ 07632 TEL 201 2242333 FA: 201 221 2330 Aug 2, 2016 To Whom it May Concern, Hans Biomed manufactures ExponentT M DBM and PureBone Demineralized Cancellous products for Bioventus. ExponenPM DBM product was cleared under the trade name SurFuse Gel and Putty and ExFuse Gel and Putty (the clearance letter can be downloaded directly from www.fda.gov). ExponentT M DBIVI products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically creased osseous defects or osseous defects created from traumatic injury to the bone. Should you have any further questions, please feel free to contact me directly. Best regards, Hans Biomed USA, Inc. WWW HANSBIOMED. COM
12. HCT/Ps REGULATED AS MEDICAL DEVICES 11. HCT/Ps DESCRIBED IN 21 CFR 1271.10 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) (See reverse side for instructions) PART I - ESTABLISHMENT INFORMATION 3. OTHER FDA REGISTRATIONS a. BLOOD FDA 2830 b. DEVICES FDA 2891 NO. NO. d. INACTIVE PART II - PRODUCT INFORMATION 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps Establishment Functions Types of HCT / Ps FEI: 3003828812 See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION (FDA Establishment Identifier) a. INITIAL REGISTRATION / LISTING b. ANNUAL REGISTRATION / LISTING c. CHANGE IN INFORMATION Recover Screen Test Package Process Store Label Distribute VALIDATION--FOR FDA USE ONLY VALIDATED BY FDA:21-DEC-2014 DISTRICT: Int'l Operations Group PRINTED BY FDA:02-FEB-2015 13. HCT/Ps REGULATED AS DRUGS OR BIOLOGICAL DRUGS 14. PROPRIETARY NAME(S) 1 c. DRUG FDA 2656 NO. 4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code) Hans Biomed Corporation a. Bone b. Cartilage *** See full text on next page 64, yuseong-daero 1628 beon-gil Youseong-gu, Daejeon, KR-30 Korea, Republic Of c. Cornea d. Dura Mater a. PHONE 822-466-2266 ET b. SATELLITE RECOVERY ESTABLISHMENT (MANUFACTURING ESTABLISHMENT FEI NO. c. TESTING FOR MICRO-ORGANISMS ONLY 5. ENTER CORRECTIONS TO ITEM 4 e. Embryo f. Fascia g. Heart Valve h. Ligament SIP Directed Anonymous Bellagen-F 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code) Hans Biomed Corporation Attn: Lucy Choi c/o Calways 105 Welker Ct Campbell, California 95008 i. Oocyte j. Pericardium k. Peripheral Blood Stem l. Sclera SIP Directed Anonymous Autologous Family Related Allogeneic a. PHONE 408-676-9063 ET 7. ENTER CORRECTIONS TO ITEM 6 b. PHONE m. Semen n. Skin SIP Directed Anonymous *** See full text on next page 8. U.S. AGENT Shane Liu, RAC Calways International, LLC 105 Welker Ct, Campbell, California 95008 o. Somatic Cell Therapy Products p. Tendon q. Umbilical Cord Blood Autologous Family Related Allogeneic Autologous Family Related Allogeneic a. E-MAIL fda@calways.net 9. REPORTING OFFICIAL'S SIGNATURE a. TYPED NAME Lucy Choi b. E-MAIL fda@calways.net c. TITLE Regulatory Affairs Manager FORM FDA - 3356 (5/14) 408-676-9063 d. DATE 20-DEC-2014 r. Vascular Graft s. t. u. v.
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) (See reverse side for instructions) ADDITIONAL INFORMATION: 1. REGISTRATION NUMBER (FDA Establishment Identifier) FEI: 3003828812 See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017 2 Proprietary Name(s): a. Bone SureOss, OsteoGrow, SureChip, SureBlock, Genesis, Pedi-Stick, INGROSS, CANOSS, OsteOss, Genesis Sponge, ExFuse, SurFuse, n. Skin Belloderm, Bellagen, SureDerm, Sheba, RegenCell, AlloCover, GPS, CPS FORM FDA - 3356 (5/14) Page: 2