{"publicDeviceRecordKey":"6b902ab2-8284-452e-8ebe-e6e18dab34d3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-09-23T00:00:00.000Z","devicePublishDate":"2017-01-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00650551068921","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DEPTHALON®","versionModelNumber":"2102-06-051-NS","catalogNumber":"2102-06-051-NS","dunsNumber":"039576871","companyName":"PMT CORPORATION","deviceCount":1,"deviceDescription":"DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"800-626-5463","phoneExtension":null,"email":"info@pmtcorp.com"},{"phone":"800-626-5463","phoneExtension":null,"email":"intl@pmtcorp.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K151790","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32556","gmdnPTName":"Depth electrode","gmdnPTDefinition":"An electrical conductor intended to be temporarily placed (\u003c 30 days) beneath 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 fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GZL","productCodeName":"Electrode, Depth"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Spacing 7 Millimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Recording Depth 37 Millimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Contact Length 2 Millimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Main Tube Length 32 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"78"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"58"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Hydrogen Peroxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}