<?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>5aca78f2-1988-40fb-9347-db20b4c99b68</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-08-30</publicVersionDate><devicePublishDate>2023-04-05</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>16975424192246</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>06975424192249</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Inner Case</pkgType></identifier><identifier><deviceId>06975424192249</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><identifier><deviceId>26975424192243</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>16975424192246</containsDINumber><pkgQuantity>4</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Case</pkgType></identifier></identifiers><brandName>Exact Medical Manufacturing, Inc.</brandName><versionModelNumber>FGM-D0315</versionModelNumber><catalogNumber>FGM-D0315</catalogNumber><dunsNumber>014464314</dunsNumber><companyName>EXACT MEDICAL MANUFACTURING, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Ophthalmic Aperture Drape, 40x40cm, 6cm dia. Aperture
</deviceDescription><DMExempt>true</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts/><gmdnTerms><gmdn><gmdnCode>47783</gmdnCode><gmdnPTName>Patient surgical drape, single-use</gmdnPTName><gmdnPTDefinition>A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KKX</productCode><productCodeName>Drape, Surgical</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>