Derm-MaxxTM Dermal Matrix is dehydrated dermis from donated human tissue processed through the Tutoplast® tissue sterilization process. The implant is
preserved by the Tutoplast® tissue sterilization process which retains the three- dimensional collagen structure responsible for the multidirectional, mechanical
properties of the original dermal tissue. The implant is regulated as 361 human cell and tissue product (HCT/Ps) as defined in USFDA 21 CFR 1271 and is restricted to homologous use for the repair, replacement, reconstruction, or augmentation of soft tissue by a qualified healthcare professional (e.g., physician). The implant is provided sterile and requires rehydration prior to use.