{"publicDeviceRecordKey":"ebba10fa-23f0-4f3d-ace9-7330e3222cfd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-04-01T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":"2019-01-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M595D6250","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"D625","catalogNumber":"D625","dunsNumber":"009900424","companyName":"PARKELL, INC.","deviceCount":1,"deviceDescription":"Metal Probes for Gentle Pulse™ \u0026 Digitest™ Pulptesters (1 Short \u0026 1 Long)","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"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":"6312491134","phoneExtension":null,"email":"customerservice@parkell.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"13187","gmdnPTName":"Dental pulp analysis system","gmdnPTDefinition":"An assembly of devices designed to evaluate the pulpal vitality of teeth by electrically stimulating the nerve tissue of the pulp. The electric current needed to obtain a patient response to the stimulus is a measure of the condition of the dental pulp. The system typically includes a high frequency electronic oscillator, cables, and electrodes to apply the electrical signal; a display may be included. The system is used for determination of pulp necrosis, pulpitis, and involvement of teeth that approximate lesions (i.e., teeth that are next to diseased tissue).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EAT","productCodeName":"Tester, Pulp"}]},"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":[]}}