Ossogen™ Mineralized Cortical Cancellous Allograft Particulate Jar

Particulate Type: Mineralized Cortical Cancellous

Mixture Volume: 70% Cortical, 30% Cancellous

Particulate Volume: 1.0cc

Particulate Size: 250-1000µm

Packaging Style: Screw Top Jar

Donor Screening for Tissue Procurement

An appropriate blood sample from the donor is tested for relevant communicable disease tests by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493 using, when available, FDA-licensed test kits. DCIDS only releases tissue for transplantation that has negative results for:

• Anti-HIV-1 and anti-HIV-2
• HIV-1/HBV/HCV NAT
• Hepatitis B surface Antigen (HBsAg)
• Hepatitis B Core total antibody (anti-HBc)
• Hepatitis C antibody (anti-HCV)
• Syphilis
• HTLV I/II

Additional tests for other communicable diseases, such as West Nile Virus, T. Cruzi, Cytomegalovirus and Epstein Barr Virus may have been performed. The results of all additional communicable disease tests have been evaluated by the Medical Director and have been found acceptable according to regulations, standards and DCIDS policies and procedures. These test results, donor risk assessment questionnaire, physical assessment/examination and other available relevant donor records have been evaluated by DCIDS and deemed eligible for transplant by a licensed physician Medical Director.

Processing

Technical Quality Assurance standards are rigorously maintained by DCI Donor Services – Tissue Bank (DCIDS). Tissue is processed aseptically in a controlled, ultra clean environment and includes the final step of sterilization by gamma irradiation. This tissue was processed using some or all of the following agents: Bacitracin, Polymyxin B Sulfate, Gentamicin, Brij® 35, Nonoxynol-9, NP-40, alcohol and/or hydrogen peroxide. Although the tissue was rinsedwith sterile water or sterile saline throughout the processing procedure, traces of the medications and chemicals may remain. Low dose gamma radiation is applied to product to achieve a sterility assurance level (SAL) of 10-6.

Certifications

• American Associated of Tissue Banks
• International Organization of Standardization
• Food and Drug Administration
• State Licensing Agencies where applicable