<?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>6b223895-880b-46e4-a9a6-025c666ff8c7</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2025-06-24</publicVersionDate><devicePublishDate>2016-09-24</devicePublishDate><deviceCommDistributionEndDate>2016-09-24</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>20884521189208</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>10884521189201</containsDINumber><pkgQuantity>6</pkgQuantity><pkgDiscontinueDate>2016-09-24</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>CASE</pkgType></identifier><identifier><deviceId>10884521189201</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>Syneture</brandName><versionModelNumber>US1662</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>058614483</dunsNumber><companyName>Covidien LP</companyName><deviceCount>1</deviceCount><deviceDescription>Custom Suture Pack,(2) CL-975;(2) CLS-953;(3) GS-62-M;(1) S-176;(1) S-195;(1) S-317;(2) SL-692;(2) VP-523;(2) VP-521-X;(3) VP-522-X;(1) VP-556-X;(3) VP-557-X;(1) VP-558-X</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</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(508)261-8000</phone><phoneExtension xsi:nil="true"/><email>covidien.udi@covidien.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>13892</gmdnCode><gmdnPTName>Suture kit, medicated</gmdnPTName><gmdnPTDefinition>A collection of sterile instruments, dressings, and pharmaceuticals necessary to perform a suturing procedure. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>OVN</productCode><productCodeName>Suture kit</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="130"/><storageHandlingLow unit="Degrees Fahrenheit" value=""/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>