Device Dossier

Surgical procedure kit, general-purpose, single-use, non-medicated

Device Dossier for Surgical procedure kit, general-purpose, single-use, non-medicated (Surgical procedure kit, general-purpose, single-use,…

Intended purpose

The EMG Kit Procedure Packs are a collection of finished electrodes and endotracheal tubes with integrated electrodes that will be used with a nerve stimulating system to provide EMG information on the status of nerve integrity during a single surgical procedure. These devices must be used in connection with the Neurovision nerve stimulating system or any approved IEC 60601-1, compatible EMG monitoring system with 42802 DIN compatible connectors.

TGA Public Summary