<?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>bdb79d70-3b97-495f-97a8-8921d1d53194</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2018-03-29</publicVersionDate><devicePublishDate>2017-07-13</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00846159002003</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>Scanlan® TIP-GUARD™ instrument protectors - Tinted</brandName><versionModelNumber>1001-301</versionModelNumber><catalogNumber>1001-301</catalogNumber><dunsNumber>023055619</dunsNumber><companyName>SCANLAN INTERNATIONAL INC</companyName><deviceCount>1</deviceCount><deviceDescription>Scanlan® TIP-GUARD™ instrument protectors - Original - Red Tinted, 3.2 x 25.4 mm (100 pieces per package)</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>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>651-298-0997</phone><phoneExtension xsi:nil="true"/><email>vanderpoelw@scanlangroup.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>34004</gmdnCode><gmdnPTName>Surgical instrument guard, reusable</gmdnPTName><gmdnPTDefinition>A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FWZ</productCode><productCodeName>Operating Room Accessories Table Tray</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>