Device Dossier
Neurophysiologic monitoring system
Device Dossier for Neurophysiologic monitoring system (Neurophysiologic monitoring system, Class IIa, sponsor DePuy Synthes). ARTG record, intended…
- GMDN category: Neurophysiologic monitoring system
Intended purpose
A series of individual components intended for use in intraoperative procedures for patient-connected intraoperative neuromonitoring where an appropriate neuromonitoring machine is also used. The components transmit energy from a neuromonitoring machine that allows for triggered EMG stimulation and subsequent recording of the stimulus from the muscle whose nerve was initially stimulated.