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"50/50" Corticocancellous Irradiated Mineralized Bone Matrix (MBM) Allograft
*Corticocancellous Mineralized Bone Matrix Allograft in one vial
*Particle size: .250 - 1.00mm
*Human Allograft Material provides osteoconductive and osteoinductive matrix
*Stimulates bone formation while providing a scaffold for new bone growth
*Tissue processing in accordance with AATB standards and FDA regulations
*Available in 1.0cc, 2.0cc and 5.0cc vials
Product Description:
This product contains Human Allograft Material (referred to as “Graft”) collected from human cadaveric donors.
All tissue processed for Impladent Ltd. is recovered by U.S. tissue banks as well as a completed donor chart for the enclosed product including but not limited to: serology results, preprocessing culture results, medical and social history evaluation and serodilution calculations that are conducted by or contract tested for the tissue bank. It has been reviewed and approved for transplantation by the tissue bank’s Medical Director.
Donor screening and testing is performed in accordance with the American Association of Tissue Banks (AATB) standards and U.S. Food and Drug Administration (FDA) regulations. All processing documentation has been reviewed and approved by the tissue bank’s Quality Assurance department; each lot of product is manufactured using tissue from a single donor. There is no pooling of donor tissue.
A donor serum sample is tested by a CLIA Certified Lab using FDA licensed screening tests and found to be negative or non-reactive for antibodies to human immunodeficiency virus type 1 and type 2 (anti-HIV 1 and anti-HIV 2), hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HbcAb), antibodies to the hepatitis C virus (anti-HCV), and the human T-lymphotrophic virus type I antibody (anti-HTLV I). The serum tests negative for syphilis using a FDA licensed confirmatory test. The donor also tests negative for HIV using Polymerase Chain Reaction (PCR) technology or an FDA-licensed NAT test.
