36e79a99-7e87-497a-a2dd-6a46ec6655d7UpdatePublished52019-12-022016-08-082019-11-18Not in Commercial DistributionM27240M081SecondaryHIBCC10381780034766PrimaryGS1Integra®40M08531408342INTEGRA NEUROSCIENCES IMPLANT (FRANCE)1The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(800)654-2873custsvcnj@integralife.comK96194200032556Depth electrodeAn electrical conductor intended to be temporarily placed (< 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.falseActiveGZLELECTRODE, DEPTHDevice Size Text, specifyInsertion needle 64mm LengthSpecial Storage Condition, SpecifyStore in a cool, dry placetruefalse