{"publicDeviceRecordKey":"024acf72-c21b-4a6b-ab2d-53a1b8ee11bd","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-12-16T00:00:00.000Z","devicePublishDate":"2022-12-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00652221075673","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"3M™ AlastiK™","versionModelNumber":"406-612","catalogNumber":"406-612","dunsNumber":"008256356","companyName":"3M UNITEK CORPORATION","deviceCount":1,"deviceDescription":"3M™ AlastiK™ Continuous Chains Bobbin, 406-612, C-1, Clear, 1/Ea","DMExempt":false,"premarketExempt":true,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)228-3957","phoneExtension":null,"email":"3Mhealthcarecompliance@mmm.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62073","gmdnPTName":"Orthodontic inter-bracket elastic chain","gmdnPTDefinition":"A non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ECI","productCodeName":"BAND, ELASTIC, 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":[]}}