<?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>6d8a0b21-8de2-4d95-a481-fd4de9e324b9</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-10-14</publicVersionDate><devicePublishDate>2019-11-28</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08033390167253</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>SMR Shoulder</brandName><versionModelNumber>9013.75.343</versionModelNumber><catalogNumber>9013.75.343</catalogNumber><dunsNumber>432066322</dunsNumber><companyName>LIMACORPORATE SPA</companyName><deviceCount>1</deviceCount><deviceDescription>SMALL-R # LONG Drill
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</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/><gmdnTerms><gmdn><gmdnCode>32390</gmdnCode><gmdnPTName>Fluted surgical drill bit, reusable</gmdnPTName><gmdnPTDefinition>A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a &quot;twist drill&quot;, has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MBF</productCode><productCodeName>Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented</productCodeName></fdaProductCode><fdaProductCode><productCode>KWS</productCode><productCodeName>Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented</productCodeName></fdaProductCode><fdaProductCode><productCode>KWT</productCode><productCodeName>Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented</productCodeName></fdaProductCode><fdaProductCode><productCode>PHX</productCode><productCodeName>Shoulder Prosthesis, Reverse Configuration</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>SMALL-R # LONG</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>