{"publicDeviceRecordKey":"0990fc8d-b81f-429b-8902-709f69bc2004","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2021-11-16T00:00:00.000Z","devicePublishDate":"2016-09-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"J011600501100","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"N.A.","versionModelNumber":"600-501-10","catalogNumber":null,"dunsNumber":"315427286","companyName":"DENTAURUM GmbH \u0026 Co.KG","deviceCount":1,"deviceDescription":"Sectional screw, bent, Stainless steel, Medium","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":[{"phone":"+1(800)523-3946","phoneExtension":null,"email":"info@dentaurum-us.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65678","gmdnPTName":"Orthodontic palate expander screw, self-removable","gmdnPTDefinition":"An orthodontic device intended to be used as part of a self-removable palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is not fixed to the oral cavity so that it can be temporarily removed by the patient during the treatment period (e.g., for eating). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DYJ","productCodeName":"RETAINER, SCREW EXPANSION, ORTHODONTIC"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"No special storage conditions required"}]},"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":[]}}