{"publicDeviceRecordKey":"2b977f7c-20c0-4a0f-b38c-e6840df35617","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2023-07-18T00:00:00.000Z","devicePublishDate":"2015-10-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B049ACP210","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Pectoralis Implant","versionModelNumber":"ACP 2-1","catalogNumber":"ACP 2-1","dunsNumber":"058759296","companyName":"Hanson Medical, Inc.","deviceCount":1,"deviceDescription":"Non-sterile, silicone, pectoralis implant, pair.","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":"K973729","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"48162","gmdnPTName":"Pectoral implant, non-sterile","gmdnPTDefinition":"A non-sterile implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer. It is intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"MIC","productCodeName":"Implant, Muscle, Pectoralis"}]},"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}