<?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>6728cc2d-7ba7-4f86-8d29-e80fef49c302</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2024-09-02</publicVersionDate><devicePublishDate>2018-09-11</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00821925012196</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>EVONOS</brandName><versionModelNumber>134000</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>007198742</dunsNumber><companyName>Gyrus ACMI, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>VOCOM VOCAL CORD MEDIALIZATION TRIAL 3MM DISPLACEMENT STAINLESS STEEL</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>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/><gmdnTerms><gmdn><gmdnCode>62558</gmdnCode><gmdnPTName>General-purpose curette</gmdnPTName><gmdnPTDefinition>A hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FSM</productCode><productCodeName>TRAY, 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>