<?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>474b5b6b-66a2-4eba-93b4-b027f1d0e1ba</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>8</publicVersionNumber><publicVersionDate>2023-06-02</publicVersionDate><devicePublishDate>2015-08-17</devicePublishDate><deviceCommDistributionEndDate>2015-08-22</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>04046963633301</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><identifier><deviceId>04046963633295</deviceId><deviceIdType>Unit of Use</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>Premilene</brandName><versionModelNumber>C2090496</versionModelNumber><catalogNumber>C2090496</catalogNumber><dunsNumber>511268005</dunsNumber><companyName>B BRAUN SURGICAL SA</companyName><deviceCount>36</deviceCount><deviceDescription>PREMILENE 4/0 (1.5) 45CM 2XHR17 (M)CV</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)282-9000</phone><phoneExtension xsi:nil="true"/><email>GUDID.BBMUS_Service@bbraun.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>13909</gmdnCode><gmdnPTName>Polyolefin/fluoropolymer suture, monofilament</gmdnPTName><gmdnPTDefinition>A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GAW</productCode><productCodeName>SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="45.00"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Thread Material : polypropylene</sizeText></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Size of Thread (USP - Others) : 4/0</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>