<?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>fb763e6d-d736-4ef1-88ae-2280b9089bd1</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2023-07-06</publicVersionDate><devicePublishDate>2021-11-02</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00190776205379</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>Millennium</brandName><versionModelNumber>72-427119</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>792528510</dunsNumber><companyName>Avalign Technologies, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>KLEINSASSER SUCTION  WORKING LENGTH  OVERALL METER</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>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>+1(877)289-1096</phone><phoneExtension xsi:nil="true"/><email>product.questions@avalign.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>33452</gmdnCode><gmdnPTName>Tonsil dissector, reusable</gmdnPTName><gmdnPTDefinition>A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used during the dissection of the tonsils during ear/nose/throat (ENT) surgery. It can be designed in several configurations, e.g., with a shaft that terminates at the distal end with a rounded, curved or angled tip, or it may be double-ended. The tip may be pointed, flat, sharp or blunt and angled or straight from the shaft and may or may not be serrated. It is made of high-grade stainless steel, available in various shapes and sizes, and may include suction capabilities. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KCB</productCode><productCodeName>TUBE, TONSIL SUCTION</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>