Tissue Source: Surgenex
Surgenex® is an industry leading biopharmaceutical company, providing regenerative medicine solutions that set the industry standard in quality and safety. Surgenex® uses its patented Excellion® process to produce minimally manipulated products that adhere to strict regulatory standards. Following these standards allows Surgenex® to sell approved allograft products with confidence to healthcare providers. This human tissue allograft is processed and packaged by Surgenex.
All tissue was recovered, processed, stored and distributed for use in accordance with the standards of the American Association of Tissue Banks (AATB), the FDA requirements for Human Cellular and Tissue Based Products (HCT/Ps 21 CFR Part 1271), and applicable State regulations. Surgenex® has determined the Donor to be eligible, based on the results of screening and testing. Screening includes a review of medical and social history, available hospital records, infectious disease testing, autopsy reports (if performed), and physical examination of the Donor, at the time of recovery. The Donor has been tested using FDA licensed, approved, or cleared donor screening test kits. Communicable disease testing has been performed by a laboratory registered with the FDA to perform donor testing in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS).
• Store at ambient temperature
• Do not freeze. No refrigeration is necessary.
THIS ALLOGRAFT IS SUPPLIED STERILE
This tissue allograft has been sterilized, via Gamma irradiation, to a SAL of 10-6 (Sterility Assurance Level). Allografts are processed using some or all of the following agents: physiological buffers, acids, alcohols, hydrogen peroxide and traces of these may remain.