<?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>c5489454-2365-4f52-b49c-cf87b55e8113</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2023-06-07</publicVersionDate><devicePublishDate>2016-08-23</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D7700701993</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>REMOVAL SCREW KIT</brandName><versionModelNumber>RSK-E</versionModelNumber><catalogNumber>RSK-E</catalogNumber><dunsNumber>433815198</dunsNumber><companyName>SWEDEN &amp; MARTINA SPA</companyName><deviceCount>1</deviceCount><deviceDescription>REMOVAL SCREW KIT FOR OUTLINK2
</deviceDescription><DMExempt>true</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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>844.862.7846</phone><phoneExtension xsi:nil="true"/><email>info.us@sweden-martina.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K222640</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>45147</gmdnCode><gmdnPTName>Dental/maxillofacial surgical procedure kit, non-medicated, reusable</gmdnPTName><gmdnPTDefinition>A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KCT</productCode><productCodeName>Sterilization Wrap Containers, Trays, Cassettes &amp; Other Accessories</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>