{"publicDeviceRecordKey":"a4ef1642-e8b8-4ab2-a76c-a5e48f4ddbd1","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-09-05T00:00:00.000Z","devicePublishDate":"2022-08-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D716OSA02191","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ProFile Orifice Opener","versionModelNumber":"OSA0219","catalogNumber":"OSA0219","dunsNumber":"942778564","companyName":"TULSA DENTAL PRODUCTS LLC","deviceCount":1,"deviceDescription":"OS:asst 6pk 30-40-50-19mm ","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"40529","gmdnPTName":"Rotary/reciprocating endodontic file/rasp, reusable","gmdnPTDefinition":"A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EKS","productCodeName":"FILE, PULP CANAL, ENDODONTIC"}]},"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":[]}}