<?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>f7fba7f8-393f-44a6-a8a2-cf9666d7d3a4</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2021-11-05</publicVersionDate><devicePublishDate>2021-10-28</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00690521011069</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>Batrik Non-Sterile Suture Tags White</brandName><versionModelNumber>911-1045</versionModelNumber><catalogNumber>911-1045</catalogNumber><dunsNumber>243880700</dunsNumber><companyName>Batrik Medical Manufacturing Inc</companyName><deviceCount>1</deviceCount><deviceDescription>&quot;Suture Clamp Tags, Radio Opaque, Non-Sterile, White, Standard ø 0.06&quot;&quot; x 0.5&quot;&quot;L&quot;
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>514-631-7988</phone><phoneExtension xsi:nil="true"/><email>info@surgmed.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>13895</gmdnCode><gmdnPTName>Operative-site suture holder</gmdnPTName><gmdnPTDefinition>A device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KDC</productCode><productCodeName>Instrument, Surgical, Disposable</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep Dry</storageHandlingSpecialConditionText></storageHandling><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep away from sunlight</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>