{"publicDeviceRecordKey":"41886607-a1b8-42c8-a6ed-51b96ce789fb","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2018-08-20T00:00:00.000Z","devicePublishDate":"2018-07-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"40649111069803","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00649111069805","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Sklar®","versionModelNumber":"21-502","catalogNumber":null,"dunsNumber":"006966006","companyName":"SKLAR CORPORATION","deviceCount":12,"deviceDescription":"PROBE W/EYE 6\" BX12","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61100","gmdnPTName":"Neurosurgical probe","gmdnPTDefinition":"A non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HXB","productCodeName":"PROBE"}]},"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":[]}}