{"publicDeviceRecordKey":"721388c7-e149-4bf8-8fda-bf05011e3c44","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-09-29T00:00:00.000Z","devicePublishDate":"2021-09-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D701PD2","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Kool-Dam","versionModelNumber":"PD","catalogNumber":null,"dunsNumber":"001006089","companyName":"PULPDENT CORPORATION","deviceCount":1,"deviceDescription":"Light cure, heatless liquid dam.\nKIT: 2 x 3 mL syringes + 20 applicator tips\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45004","gmdnPTName":"Rubber dam, non-latex","gmdnPTDefinition":"A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIE","productCodeName":"Dam, Rubber"}]},"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":[]}}