{"publicDeviceRecordKey":"f0407ec5-b879-4587-87d5-0a36f7742cc5","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-12-15T00:00:00.000Z","devicePublishDate":"2022-12-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10889989009016","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00889989009019","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Alexander Signature","versionModelNumber":"354-3514","catalogNumber":null,"dunsNumber":"154614119","companyName":"ORMCO CORPORATION","deviceCount":10,"deviceDescription":"ALEX.SIGNATURE G-OFF ASSY UR2BI -8T 4A 018","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+18008541741","phoneExtension":null,"email":"ormcocustcare@ormco.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46581","gmdnPTName":"Orthodontic bracket, metal","gmdnPTDefinition":"A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EJF","productCodeName":"BRACKET, METAL, ORTHODONTIC"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Slot size 018, Torque -8, Angulation 4"}]},"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":[]}}