{"publicDeviceRecordKey":"f3b90cf9-a531-400b-9ee6-7b96a8a32ed7","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2015-09-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00841365106958","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Best Medical International","versionModelNumber":"10174-7-12","catalogNumber":null,"dunsNumber":"086352655","companyName":"BEST MEDICAL INTERNATIONAL, INC.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K061638","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46844","gmdnPTName":"Brachytherapy source spacer","gmdnPTDefinition":"A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. It typically has a cylindrical form (of around 0.5 cm in length and less than 1 mm in diameter) and is made of bioabsorbable polymer materials. It may be used for the primary treatment of tumours (e.g., prostate cancer), or to treat unresectable tumours, recurring tumours, or residual disease. It is typically placed in the body by means of a remote-afterloading applicator using ultrasonic or fluoroscopic guidance.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KXK","productCodeName":"Source, Brachytherapy, Radionuclide"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}