33ccb071-1e46-4305-9ee4-d3afefeb6dcfUpdatePublished92025-09-042016-09-24In Commercial DistributionB006PSS26DF52PrimaryHIBCCB006PSS26DF1Unit of UseHIBCC00810155862152SecondaryGS1NONENONEDSPPSS26DF-5182057401Neurovision Medical Products, Inc.5falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseMR Unsafetruefalse11441Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.falseActive61088Aspiration nerve-locating system probeA sterile, hand-held surgical instrument intended to apply a controlled electrical stimulus to a specific body site to locate nerves during surgery and for diagnostic purposes [electromyography (EMG)], as well as to provide a dry surgical field via suction cannula. It is typically used in open surgical procedures and is intended to be connected to an appropriate EMG pulse generating and recording device and a source of suction. This is a single-use device.falseActiveIKTElectrode, Needle, Diagnostic ElectromyographETNStimulator, Nervetruefalse