<?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>99b9e74f-8c3b-483b-9af8-53c16e369b31</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2023-01-26</publicVersionDate><devicePublishDate>2018-08-31</devicePublishDate><deviceCommDistributionEndDate>2023-01-25</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M752TMDCSA15</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>M752TMDCSA10</containsDINumber><pkgQuantity>30</pkgQuantity><pkgDiscontinueDate>2023-01-25</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>outer box</pkgType></identifier><identifier><deviceId>M752TMDCSA10</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>Stradis Medical, LLC</brandName><versionModelNumber>TMDCSA1</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>174262477</dunsNumber><companyName>STRADIS MEDICAL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Dressing Change Tray W/CHG</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</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>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>1-800-424-8520</phone><phoneExtension xsi:nil="true"/><email>cs@stradishealthcare.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>34059</gmdnCode><gmdnPTName>Wound dressing kit, medicated</gmdnPTName><gmdnPTDefinition>A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MCY</productCode><productCodeName>Wound Dressing Kit</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>