<?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>8d81a4bb-4181-4235-bd6f-e0c9e3c9d328</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2024-09-11</publicVersionDate><devicePublishDate>2018-06-29</devicePublishDate><deviceCommDistributionEndDate>2023-01-10</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M752SS93355</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>M752SS93350</containsDINumber><pkgQuantity>25</pkgQuantity><pkgDiscontinueDate>2023-01-10</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>outer box</pkgType></identifier><identifier><deviceId>M752SS93350</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Stradis Medical, LLC.</brandName><versionModelNumber>SS9335</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>174262477</dunsNumber><companyName>STRADIS MEDICAL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Sani Sleeve™ Barrier Protection For Handpieces And Hoses</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</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>true</rx><otc>false</otc><contacts><customerContact><phone>770-962-2425</phone><phoneExtension xsi:nil="true"/><email>SALES@STRADISHEALTHCARE.COM</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>12535</gmdnCode><gmdnPTName>Medical equipment/instrument drape, single-use</gmdnPTName><gmdnPTDefinition>A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KQM</productCode><productCodeName>Camera, Surgical And Accessories</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>