Summary for ARTG Entry:
Integra Neurosciences Pty Ltd - Intracranial Pressure-Temperature Monitoring Kit, 110-4BT - Catheter,
ARTG entry for
Medical Device Included Class III
Integra Neurosciences Pty Ltd
Unit 3 / 24-30 Winterton Road,CLAYTON, VIC, 3168
ARTG Start Date
Medical Device Class III
- 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.
5955 Pacific Center Boulevard
San Diego, CA, 92121
United States Of America
1. Intracranial Pressure-Temperature Monitoring Kit, 110-4BT - Catheter, neurological, ventricular
Medical device system
32585 Catheter, neurological, ventricular
Kit consists of a catheter with a transducer and a thermistor at the distal end that monitors intracranial
pressure and temperature when attached to a monitor. Kit includes accessories to insert the catheter
through the skull and secure into place. A zero adjustment tool is supplied to adjust the monitor display via
the transducer connector on the catheter.
The Camino Intracranial Pressure-Temperature Monitoring Kit is intended to measure intracranial pressure
and temperature in the parenchyma.
Nil variant (as 1 device) 0
No Specific Conditions included on Record
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