{"publicDeviceRecordKey":"3727890e-05f7-4084-9f38-3f7775f53182","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2026-04-09T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00841823106940","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Subdural Electrode","versionModelNumber":"MS08L-SP10X-E00","catalogNumber":"MS08L-SP10X-E00","dunsNumber":"174813410","companyName":"Ad-Tech Medical Instrument Corporation","deviceCount":1,"deviceDescription":null,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)776-1555","phoneExtension":null,"email":"sales@adtechmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K191186","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32545","gmdnPTName":"Cortical electrode","gmdnPTDefinition":"A sterile, invasive, electrical conductor that is temporarily placed (\u003c 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GYC","productCodeName":"ELECTRODE, CORTICAL"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"To be stored and used within typical hospital/office room ambient temperature and humidity conditions"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}