{"publicDeviceRecordKey":"33657e60-9a91-44f8-b276-ab41b96d8b77","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-03-17T00:00:00.000Z","devicePublishDate":"2017-11-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"W41020AU201P0001","deviceIdType":"Primary","deviceIdIssuingAgency":"ICCBBA","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Epicel (cultured epidermal autografts)","versionModelNumber":"0","catalogNumber":null,"dunsNumber":"079745570","companyName":"VERICEL CORPORATION","deviceCount":1,"deviceDescription":"Epicel (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.\nEpicel 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.","DMExempt":false,"premarketExempt":false,"deviceHCTP":true,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":true,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-232-7546","phoneExtension":null,"email":"customercare@vcel.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"BH990200","supplementNumber":"0"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61662","gmdnPTName":"Cultured skin autograft/xenograft","gmdnPTDefinition":"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.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OCE","productCodeName":"Cultured Epithelial Autograft"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Area/Surface Area","size":{"unit":"Square centimeter","value":"50"},"sizeText":null,"sizeString":"Area/Surface Area: 50 Square centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"23"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"13"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"73"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"55"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Inspect the Epicel packaging and ensure that it is intact. Do not use Epicel if package is opened or damaged."},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store Epicel in the original shipping container in which it is received. Do not remove from original shipping container until ready for use."},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep Epicel out of the operating room until ready for application"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Inspect the medium in which Epicel is transported. Do not use an Epicel graft if the medium appears cloudy."},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Do 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. "},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Maintain the shipping carton closed and at cool room temperature (13 to 23°C, 55 to 73°F)."}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}