<?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>018be9f3-c06f-4c0d-a6c2-f8fc20a7b58f</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2021-01-12</publicVersionDate><devicePublishDate>2021-01-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00190660180997</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>Ambler Surgical</brandName><versionModelNumber>Toynbee ear speculum</versionModelNumber><catalogNumber>86-705</catalogNumber><dunsNumber>015272206</dunsNumber><companyName>AMBLER SURGICAL CORP.</companyName><deviceCount>1</deviceCount><deviceDescription>Toynbee ear speculum, oval ends, set of 4 includes sizes #1 - #4 (86-701, 86-702, 86-703 and 86-704)</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</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>+1(888)407-0006</phone><phoneExtension>0</phoneExtension><email>sales@amblersurgical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35348</gmdnCode><gmdnPTName>Self-retaining ear speculum</gmdnPTName><gmdnPTDefinition>A hand-held manual instrument which typically comprises two arms joined at a pivot point and designed for expanding or stretching the tissue around the ear orifice when inserted and opened. It has a blunt distal tip and is used for examination or surgery, typically during ear/nose/throat (ENT) intervention. It is usually made of stainless steel with a self-retaining or adjustable mechanism and is available in various sizes, shapes and contours. 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>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>