{"publicDeviceRecordKey":"851da90e-67f1-480c-b4b4-c70791e45880","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-09-04T00:00:00.000Z","devicePublishDate":"2020-08-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"ESAM3408070","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"ESAM3408071","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"STOMA®","versionModelNumber":"3408.07","catalogNumber":"3408.07","dunsNumber":"318268125","companyName":"Storz am Mark GmbH","deviceCount":1,"deviceDescription":"Matrix retainer, Ivory, 7mm, fig.8","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":[{"phone":"+49746592600","phoneExtension":null,"email":"sam@stoma.de"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45008","gmdnPTName":"Dental matrix band tensioner","gmdnPTDefinition":"A hand-held, dental instrument designed for tightening a matrix band around a tooth that is being prepared for a dental restoration. It is a rod-like device, typically designed with a manually controlled rotating action at its distal end for insertion into and tightening of a retainerless matrix band around the tooth. When the matrix band is in place, this device is removed offering a clear field of vision. Some types may incorporate a torque control mechanism to limit over-tensioning. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JEP","productCodeName":"RETAINER, MATRIX"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}