{"publicDeviceRecordKey":"06267086-c0bd-41db-9c4f-4c74f38aae10","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-07-14T00:00:00.000Z","devicePublishDate":"2022-07-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"E2995975CS9","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"E2995975CS0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Clip\u0026Splint","versionModelNumber":"5975CS","catalogNumber":null,"dunsNumber":"481461598","companyName":"Polydentia SA","deviceCount":30,"deviceDescription":null,"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":false,"otc":false,"contacts":{"customerContact":[{"phone":"+41919462948","phoneExtension":null,"email":"info@polydentia.ch"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33204","gmdnPTName":"Dental matrix band retainer","gmdnPTDefinition":"A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DZN","productCodeName":"Instruments, Dental Hand"}]},"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":[]}}