{"publicDeviceRecordKey":"2f88f02d-687b-4592-b595-0a25cd749114","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-08-13T00:00:00.000Z","devicePublishDate":"2019-07-24T00:00:00.000Z","deviceCommDistributionEndDate":"2024-08-13T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08718755001815","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Varex Imaging","versionModelNumber":"19409-05","catalogNumber":null,"dunsNumber":"413223942","companyName":"Varex Imaging Nederland B.V.","deviceCount":1,"deviceDescription":"The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor.\nThe device is one out of the Harmony 3-series.\n","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":"14473","gmdnPTName":"X-ray film cassette holder","gmdnPTDefinition":"A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IXY","productCodeName":"Holder, Radiographic Cassette, Wall-Mounted"}]},"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":[]}}