{"publicDeviceRecordKey":"6a1bd5fa-5eee-4553-9492-ef8eedad52ef","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-07-18T00:00:00.000Z","devicePublishDate":"2015-10-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B049ACP91R0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Gluteal Implant","versionModelNumber":"ACP 9-1 R","catalogNumber":"ACP 9-1 R","dunsNumber":"058759296","companyName":"Hanson Medical, Inc.","deviceCount":1,"deviceDescription":"Non-sterile, silicone, gluteal implant, right.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1(800)771-2215","phoneExtension":null,"email":"erik@hansonmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K030809","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":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}