{"publicDeviceRecordKey":"4204ec1b-2445-42e2-8333-0902f863ecc6","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-01-09T00:00:00.000Z","devicePublishDate":"2021-08-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B1364530","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Sun Nuclear BR12 Breast","versionModelNumber":"453","catalogNumber":null,"dunsNumber":"122240021","companyName":"SUN NUCLEAR CORP.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"40631","gmdnPTName":"Multi-modality therapeutic radiation phantom, test object","gmdnPTDefinition":"A device consisting of a variety of multi-modality radiation therapy phantom designs. It can consist of an object of uniform material density or a two or three-dimensional (3-D) model containing patterns of objects, materials, or openings. It is available in both fixed and variable configurations including holders for ionization chambers, dosimeters or other radiation measurement instruments. It is a quality assurance (QA) device used in the calibration of photon and electron beam emitting radiation therapy systems and the measurement of performance attributes, e.g., beam flatness, symmetry, dose depth or geometric accuracy.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LHO","productCodeName":"Instrument, Quality-Assurance, Radiologic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}