<?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>3ef2e3c0-07c8-4515-86fc-3b75222f8610</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2023-09-07</publicVersionDate><devicePublishDate>2015-08-29</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03596010656018</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>NA</brandName><versionModelNumber>72203160</versionModelNumber><catalogNumber>72203160</catalogNumber><dunsNumber>045483575</dunsNumber><companyName>Smith &amp; Nephew, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>TWIST DRILL FLEX CRVD FOR 2.3 SA</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)821-5700</phone><phoneExtension xsi:nil="true"/><email>gudid@smith-nephew.com</email></customerContact></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>MBI</productCode><productCodeName>FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE</productCodeName></fdaProductCode><fdaProductCode><productCode>JDR</productCode><productCodeName>STAPLE, FIXATION, BONE</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>