Device typeCultured skin autograft/xenograft: A non-sterile tissue, in vitro cultivated from cells of human and animal origin, intended to cover skin wounds typically resulting from a burn injury. It is developed by ex vivo aseptic processing of a biopsy of skin from the recipient, involving enzymatic digestion and multiplication (culture) of epidermal cells combined with proliferation-arrested, murine (mouse) fibroblasts, to produce a graft of sufficient size for wound coverage. It is typically supplied by attachment to a gauze backing and may be used alone or in conjunction with split-thickness skin autografts.
FDA categoryCultured Epithelial Autograft
Device IDW41020AU201S1969
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information
Area/Surface Area50 Square centimeter