<?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>856b4f5a-c200-44aa-a9ab-252f88d0b9db</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2026-02-10</publicVersionDate><devicePublishDate>2026-02-02</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00763000659486</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>SimuPlus™</brandName><versionModelNumber>7700FS</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>006261481</dunsNumber><companyName>MEDTRONIC, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>ACCY 7700FS SIMUPLUS R/B SIZERS SIL MDR</deviceDescription><DMExempt>true</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(800)633-8766</phone><phoneExtension xsi:nil="true"/><email>Corporate.UDI@medtronic.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47684</gmdnCode><gmdnPTName>Heart valve annulus sizer, reusable</gmdnPTName><gmdnPTDefinition>A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DTI</productCode><productCodeName>SIZER, HEART-VALVE, PROSTHESIS</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Contents: 26, 28, 30, 32, 34, 36, 38, 40, 42 MM</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>