<?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>92de2f45-0def-4a1a-b1c5-cdc44ba52344</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2026-03-05</publicVersionDate><devicePublishDate>2018-09-18</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00192896011908</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>COOK EYE SPECULUM</brandName><versionModelNumber>10-1401</versionModelNumber><catalogNumber>10-1401</catalogNumber><dunsNumber>040729840</dunsNumber><companyName>SONTEC INSTRUMENTS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>COOK EYE SPECULUM WITH LOCKING SCREW SMALL SIZE SOLID BLADES</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>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(800)821-7496</phone><phoneExtension xsi:nil="true"/><email>info@sontecinstruments.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35349</gmdnCode><gmdnPTName>Eyelid speculum, reusable</gmdnPTName><gmdnPTDefinition>A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HNC</productCode><productCodeName>Specula, ophthalmic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Dry Heat Sterilization</sterilizationMethod><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>