{"publicDeviceRecordKey":"9ebd2dd7-3460-41d0-ba0d-4c2f61e0b7cd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-01-18T00:00:00.000Z","devicePublishDate":"2020-05-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033707095002","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"LEONE SPA","versionModelNumber":"A0556-90","catalogNumber":"A0556-90","dunsNumber":"432167294","companyName":"LEONE SPA","deviceCount":1,"deviceDescription":"CLASSIC SWIVEL KEY W/PLASTIC HANDLE BLU\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"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":"64768","gmdnPTName":"Orthodontic palate expander screw key","gmdnPTDefinition":"A hand-held device designed to manually adjust an orthodontic palate expander (not included), by rotating the expander’s screw, to help create space for correct upper teeth alignment. It is comprised of a handle with an expander-engaging pin at the distal end which is inserted into the screw and rotated to adjust the width of the expander. This is a reusable device intended for single patient use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JEX","productCodeName":"Plier, Orthodontic"}]},"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":[]}}