<?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>c5e23544-1168-4c10-b315-b499499e4079</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2021-06-08</publicVersionDate><devicePublishDate>2020-09-24</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>04046826103095</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>Medicon</brandName><versionModelNumber>62.18.02</versionModelNumber><catalogNumber>62.18.02</catalogNumber><dunsNumber>315492330</dunsNumber><companyName>Medicon eG. Chirurgiemechaniker-Genossenschaft</companyName><deviceCount>1</deviceCount><deviceDescription>Buck ear lancet knife 15cm </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>false</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>+490746220090</phone><phoneExtension xsi:nil="true"/><email>sales@medicon.de</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>38102</gmdnCode><gmdnPTName>Tympanotomy knife, reusable</gmdnPTName><gmdnPTDefinition>A hand-held manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JYO</productCode><productCodeName>KNIFE, EAR</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>