<?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>06759736-a12c-4af7-8279-bb73ccec21d5</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-06-11</publicVersionDate><devicePublishDate>2016-08-31</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M7161012000</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>OrthoMedFlex</brandName><versionModelNumber>101-200</versionModelNumber><catalogNumber>101-200</catalogNumber><dunsNumber>034442726</dunsNumber><companyName>ORTHOMEDFLEX LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Guide Forceps</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</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>false</rx><otc>false</otc><contacts><customerContact><phone>8446633539</phone><phoneExtension xsi:nil="true"/><email>info@orthomedflex.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>42894</gmdnCode><gmdnPTName>Implant handling forceps, scissors-like</gmdnPTName><gmdnPTDefinition>A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It has a scissors-like, self-retaining design with ring handles, is made of high-grade stainless steel and is available in various sizes. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</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>