{"publicDeviceRecordKey":"ee4cb81c-3bbe-4ae7-a7d4-4ee1e42cb729","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-02-05T00:00:00.000Z","devicePublishDate":"2017-02-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B040FRH32","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B040FRH320","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"B040FRH320","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"FlexForm Annuloplasty Ring","versionModelNumber":"FRH-32","catalogNumber":null,"dunsNumber":"939872651","companyName":"GENESEE BIOMEDICAL, INC.","deviceCount":1,"deviceDescription":"Annuloplasty Ring","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":true,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Conditional","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"800 786-4890","phoneExtension":null,"email":"info@geneseebiomedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K161815","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45578","gmdnPTName":"Mitral/tricuspid annuloplasty ring","gmdnPTDefinition":"A circular band intended to be implanted in the heart to support a mitral/tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral and tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"KRH","productCodeName":"Ring, Annuloplasty"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}