{"publicDeviceRecordKey":"ceb7320b-f9ad-421c-b3e8-acb3eb84b3c4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":12,"publicVersionDate":"2024-08-20T00:00:00.000Z","devicePublishDate":"2016-12-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B454VTP22010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"VersaWrap","versionModelNumber":"VTP-2201","catalogNumber":"VTP-2201","dunsNumber":"968882709","companyName":"Alafair Biosciences, Inc.","deviceCount":1,"deviceDescription":"VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44814","gmdnPTName":"Nerve guide, synthetic polymer, bioabsorbable","gmdnPTDefinition":"An implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap.","implantable":true,"gmdnCodeStatus":"Active"},{"gmdnCode":"35671","gmdnPTName":"Tendon spacer","gmdnPTDefinition":"An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JXI","productCodeName":"Cuff, Nerve"},{"productCode":"FTM","productCodeName":"Mesh, Surgical"},{"productCode":"OWW","productCodeName":"Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"1"},"sizeText":null,"sizeString":"Total Volume: 1 Milliliter"},{"sizeType":"Length","size":{"unit":"Inch","value":"2"},"sizeText":null,"sizeString":"Length: 2 Inch"},{"sizeType":"Width","size":{"unit":"Inch","value":"2"},"sizeText":null,"sizeString":"Width: 2 Inch"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"5"},"sizeText":null,"sizeString":"Length: 5 Centimeter"},{"sizeType":"Width","size":{"unit":"Centimeter","value":"5"},"sizeText":null,"sizeString":"Width: 5 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"2"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":{"gmdn_code":"44814","anomaly_score":-0.0000026484060663412023},"premarketSubmissions":{"premarketSubmission":[]}}