{"publicDeviceRecordKey":"fe380470-5a97-4daf-a0ab-8e1004909f4b","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-09-05T00:00:00.000Z","devicePublishDate":"2024-08-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10889813062019","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00889813062012","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Darby Dental Supply, LLC","versionModelNumber":"5252545","catalogNumber":null,"dunsNumber":"825137818","companyName":"DARBY DENTAL SUPPLY, LLC","deviceCount":4,"deviceDescription":"PHOSPHR IMGE PLATE GENDEX SZ2","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"67230","gmdnPTName":"Digital imaging phosphor plate, dental, intraoral","gmdnPTDefinition":"A thin, photostimulable, dental device intended to be placed in an appropriate cover (not included), and subsequently introduced into the oral cavity and exposed to radiation by a diagnostic imaging x-ray system to record a radiation pattern of a patient’s teeth and/or jaws. Following exposure, it is transferred, typically in a light-shielding container (not included), to a computed radiography scanner (CR) to produce a digital image of the latent image formed on the plate. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EAM","productCodeName":"Screen, intensifying, radiographic"}]},"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":[]}}