{"publicDeviceRecordKey":"0f9c51ff-daa7-453f-9e86-6609f8ab87dd","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-09-14T00:00:00.000Z","devicePublishDate":"2022-09-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D716MCPLBOX1001","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ProLube","versionModelNumber":"MCPLBOX100","catalogNumber":"MCPLBOX100","dunsNumber":"942778564","companyName":"TULSA DENTAL PRODUCTS LLC","deviceCount":1,"deviceDescription":"PROLUBE 100 BOX","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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45480","gmdnPTName":"Dental root surface conditioner","gmdnPTDefinition":"A dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIC","productCodeName":"SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING"}]},"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":[]}}