{"publicDeviceRecordKey":"a2506da3-6d05-49fa-b8ac-91b109bda7c9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-07-18T00:00:00.000Z","devicePublishDate":"2015-10-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B049M720","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Malar Implant","versionModelNumber":"M 7-2","catalogNumber":"M 7-2","dunsNumber":"058759296","companyName":"Hanson Medical, Inc.","deviceCount":1,"deviceDescription":"Non-sterile, silicone, malar 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":"K973574","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45228","gmdnPTName":"Malar prosthesis","gmdnPTDefinition":"An implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LZK","productCodeName":"Implant, Malar"}]},"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}