{"publicDeviceRecordKey":"39b79c6f-399b-4a23-80c5-7843c0fbc948","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-08-22T00:00:00.000Z","devicePublishDate":"2016-12-20T00:00:00.000Z","deviceCommDistributionEndDate":"2022-07-22T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B490502103C0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AART Calf Implant","versionModelNumber":"C","catalogNumber":"502-103C","dunsNumber":"091356894","companyName":"Aart","deviceCount":1,"deviceDescription":"Calf Sty 1 Sz 3 Sterile","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":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(775)853-6800","phoneExtension":null,"email":"customer.service@aartinc.net"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K022511","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45230","gmdnPTName":"Silicone-block tissue reconstructive material","gmdnPTDefinition":"A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MIB","productCodeName":"ELASTOMER, SILICONE BLOCK"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Dry Heat Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}