<?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>6134536c-96d1-496d-8578-ce68b8c6cbb0</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2024-02-28</publicVersionDate><devicePublishDate>2017-12-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>05060488041815</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>INTEGRA 3</brandName><versionModelNumber>Integra 3 Thermosafe Olympus 1 x SAS &amp; 1 x SAS-SE</versionModelNumber><catalogNumber>6-54-100-07</catalogNumber><dunsNumber>536139413</dunsNumber><companyName>RESEARCH INSTRUMENTS LIMITED</companyName><deviceCount>1</deviceCount><deviceDescription>Assisted Reproduction Micromanipulator and Microinjector</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</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><customerContact><phone>4546790202</phone><phoneExtension xsi:nil="true"/><email>origio@origio.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K003142</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>34169</gmdnCode><gmdnPTName>Assisted reproduction electromechanical micromanipulator</gmdnPTName><gmdnPTDefinition>An electrically-powered device designed for accurate manipulation of microscopic objects during laboratory in vitro assisted reproduction techniques (ART) [e.g., intracytoplasmic sperm injection] usually by making small movements under the visual field of a laboratory microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, syringe microinjectors, capillary tubes). The device does not perform its actions following a computerized program.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MQJ</productCode><productCodeName>MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>