{"publicDeviceRecordKey":"e805a4c4-9422-4be8-a27f-6fb19cde2202","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2015-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M724CBSMLNS1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Conform Binder Submalar®","versionModelNumber":"Size: Large","catalogNumber":"CBSM-L-NS  ","dunsNumber":"784664955","companyName":"IMPLANTECH ASSOCIATES, INC.","deviceCount":1,"deviceDescription":"Submalar Implant\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-733-0833","phoneExtension":null,"email":"info@implantech.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K973502","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}