<?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>7859d3d5-e32d-4c61-9a3e-2b564868f354</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2026-05-20</publicVersionDate><devicePublishDate>2026-05-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>05055445967352</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>Surtex</brandName><versionModelNumber>OT-020-02</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>216232502</dunsNumber><companyName>SURTEX INSTRUMENTS LTD.</companyName><deviceCount>1</deviceCount><deviceDescription>Toynbee Ear Specula Set of 4 Ref: OT-022-01 to OT-022-04 Stainless Steel</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>MR Conditional</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+442081233513</phone><phoneExtension xsi:nil="true"/><email>qa@surtex-instruments.co.uk</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>33395</gmdnCode><gmdnPTName>Ear speculum, reusable</gmdnPTName><gmdnPTDefinition>A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EPY</productCode><productCodeName>SPECULUM, ENT</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>