33657e60-9a91-44f8-b276-ab41b96d8b77UpdatePublished42021-03-172017-11-17In Commercial DistributionW41020AU201P0001PrimaryICCBBAEpicel (cultured epidermal autografts)0079745570VERICEL CORPORATION1Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.falsefalsetruefalsefalsetruetruetruetruetruetruefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-800-232-7546customercare@vcel.comBH990200061662Cultured skin autograft/xenograftA 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.trueActiveOCECultured Epithelial AutograftArea/Surface AreaStorage Environment TemperatureStorage Environment TemperatureSpecial Storage Condition, SpecifyInspect the Epicel packaging and ensure that it is intact. Do not use Epicel if package is opened or damaged.Special Storage Condition, SpecifyStore Epicel in the original shipping container in which it is received. Do not remove from original shipping container until ready for use.Special Storage Condition, SpecifyKeep Epicel out of the operating room until ready for applicationSpecial Storage Condition, SpecifyInspect the medium in which Epicel is transported. Do not use an Epicel graft if the medium appears cloudy.Special Storage Condition, SpecifyDo not store in a refrigerator or freezer. Do not refrigerate, freeze, or incubate the Epicel shipping container or its contents. Do not reuse, freeze, refrigerate, or sterilize Epicel after opening. Special Storage Condition, SpecifyMaintain the shipping carton closed and at cool room temperature (13 to 23°C, 55 to 73°F).falsefalse