<?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>0b398430-bd8b-4d4d-a678-01fe0d583dbf</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2024-10-22</publicVersionDate><devicePublishDate>2017-03-08</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00801741129018</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>XENMATRIX</brandName><versionModelNumber>1152530</versionModelNumber><catalogNumber>1152530</catalogNumber><dunsNumber>001191048</dunsNumber><companyName>Davol Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>XenMatrix AB Surgical Graft, 25 cm x 30 cm</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>true</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)562-0027</phone><phoneExtension xsi:nil="true"/><email>medical.services@bd.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>66960</gmdnCode><gmdnPTName>Extra-gynaecological surgical mesh, collagen, bioabsorbable, antimicrobial</gmdnPTName><gmdnPTDefinition>A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde), and is coated with an antimicrobial agent (e.g., rifampin, minocycline). Disposable devices associated with implantation may be supplied with the mesh.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FTM</productCode><productCodeName>Mesh, surgical</productCodeName></fdaProductCode><fdaProductCode><productCode>OXH</productCode><productCodeName>Mesh, surgical, collagen, plastic and reconstructive surgery</productCodeName></fdaProductCode><fdaProductCode><productCode>PIJ</productCode><productCodeName>Collagen surgical mesh containing drugs </productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Width</sizeType><size unit="Centimeter" value="30"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="25"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>