<?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>d6a46e07-a7aa-4f36-ac36-24b6abe322f6</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-07-27</publicVersionDate><devicePublishDate>2022-07-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B8033501980</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>ORTHOMED</brandName><versionModelNumber>OM 35-0198</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>086618626</dunsNumber><companyName>ORTHO-MED, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>WIRE CUTT.SCISS. 4 3/4&quot; ANG.(ROGER)
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</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>503-234-9691</phone><phoneExtension xsi:nil="true"/><email>support@orthomedinc.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>32885</gmdnCode><gmdnPTName>Wire cutter</gmdnPTName><gmdnPTDefinition>A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HXZ</productCode><productCodeName>Cutter, Wire</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>