<?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>0983a8f6-f94f-4548-a916-2eec4b27a6b8</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2024-02-14</publicVersionDate><devicePublishDate>2018-04-29</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00888867006607</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>Arthrex®</brandName><versionModelNumber>AR-1258</versionModelNumber><catalogNumber>AR-1258</catalogNumber><dunsNumber>131747628</dunsNumber><companyName>ARTHREX, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>TUNNEL PLUG</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</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>+1(800)934-4404</phone><phoneExtension xsi:nil="true"/><email>complaints@arthrex.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>45190</gmdnCode><gmdnPTName>Bone tunnel plug, non-cannulated</gmdnPTName><gmdnPTDefinition>A device typically intended to prevent irrigation fluid from exiting the knee joint via the tibial tunnel [a channel drilled through the knee joint during anterior cruciate ligament (ACL) repair] to maintain visualization of the joint during arthroscopy. The device typically has a rounded cap at the proximal end and tapers distally; it is not cannulated. It is inserted manually into the tunnel, is available in a variety of diameters, and is made of hard plastic. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LXH</productCode><productCodeName>ORTHOPEDIC MANUAL SURGICAL INSTRUMENT</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>