Device Dossier
Patient monitor, nerve
Device Dossier for Patient monitor, nerve (Patient monitor, nerve, Class IIa, sponsor Endotherapeutics). ARTG record, intended purpose, GMDN category —…
- GMDN category: Patient monitor, nerve
- Sponsor: Endotherapeutics
Intended purpose
Intended for identifying cranial and peripheral nervous tissue with motor or sensor function as well as monitoring the functional integrity of these structures during surgery. Indicated for use in procedures such as; intracranial, extracranial, intratemporal and extratemporal procedures as well as neck dissections, thoracic surgeries, and upper and lower extremities. Suitable for use in spinal procedures such as; degenerative treatments, pedicle screw procedures, fusion cages, rhizomotomy, orthopaedic surgery, open and percutaneous lumbar and cervical surgical procedures, and thoracic surgical procedures. Not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.