SimpliMax is a dehydrated, dual-layer amnion membrane allograft. The allograft is derived from human placental membrane collected from a consenting donor and processed aseptically. It is terminally sterilized to achieve a sterility assurance level (SAL) of 1 x 10-6 utilizing gamma irradiation. SimpliMax is packaged as a sterile product in sealed, single-use pouches. SimpliMax is processed in compliance with all current

Good Tissue Practices as mandated by the United States Food and Drug Administration and the

American Association of Tissue Banks.

Only tissues from donors meeting the prescribed criteria are processed for manufacturing SimpliMax

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