{"publicDeviceRecordKey":"ae0924a8-9292-4784-a12a-829dccdc2f6f","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-03-11T00:00:00.000Z","devicePublishDate":"2019-02-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00192029001028","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"InVu Readi-Base Brackets","versionModelNumber":"297-139RBX","catalogNumber":null,"dunsNumber":"005432299","companyName":"TP ORTHODONTICS INC","deviceCount":1,"deviceDescription":"Upper Right Central +14 Torque, +5 Tip Without    Vertical Slot, Bondable  0.46mm (.018\")","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":"K950992","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58937","gmdnPTName":"Orthodontic bracket, ceramic","gmdnPTDefinition":"A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. 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":"NJM","productCodeName":"Bracket, ceramic, orthodontic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"27"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"2"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}