{"publicDeviceRecordKey":"7101582e-7cd2-4e18-bf7a-b62b3a470b32","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-09-02T00:00:00.000Z","devicePublishDate":"2015-10-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00821925014619","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Gyrus ACMI","versionModelNumber":"140415","catalogNumber":null,"dunsNumber":"007198742","companyName":"Gyrus ACMI, LLC","deviceCount":1,"deviceDescription":"SHEA CUP PISTON LARGE, LEFT 4.0 MM LENGTH FLUOROPLASTIC\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"18002623540","phoneExtension":null,"email":"xxx@xxx.xxx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K760433","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35674","gmdnPTName":"Ossicular prosthesis, total","gmdnPTDefinition":"A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ETA","productCodeName":"Replacement, Ossicular Prosthesis, Total"}]},"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}