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.