<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>ceb7320b-f9ad-421c-b3e8-acb3eb84b3c4</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>12</publicVersionNumber><publicVersionDate>2024-08-20</publicVersionDate><devicePublishDate>2016-12-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B454VTP22010</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>VersaWrap</brandName><versionModelNumber>VTP-2201</versionModelNumber><catalogNumber>VTP-2201</catalogNumber><dunsNumber>968882709</dunsNumber><companyName>Alafair Biosciences, Inc.</companyName><deviceCount>1</deviceCount><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.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Safe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>44814</gmdnCode><gmdnPTName>Nerve guide, synthetic polymer, bioabsorbable</gmdnPTName><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.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn><gmdn><gmdnCode>35671</gmdnCode><gmdnPTName>Tendon spacer</gmdnPTName><gmdnPTDefinition>An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JXI</productCode><productCodeName>Cuff, Nerve</productCodeName></fdaProductCode><fdaProductCode><productCode>FTM</productCode><productCodeName>Mesh, Surgical</productCodeName></fdaProductCode><fdaProductCode><productCode>OWW</productCode><productCodeName>Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="1"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="2"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Inch" value="2"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="5"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Centimeter" value="5"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="Degrees Celsius" value="2"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>