Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Neurophysiologic monitoring system
ARTG entry for
Medical Device Included Class IIa
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
PO Box 134,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Oberdorf, , 4436
1. Neurophysiologic monitoring system
Single Device Product
46566 Neurophysiologic monitoring system
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.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:47:08 AEDT
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