Summary for ARTG Entry:
Integra Neurosciences Pty Ltd - LICOX Combined Oxygen and Temperature Probe, CC1.P1 - Electrode,
ion selective, oxygen
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.
Integra NeuroSciences Implants SAS
2905 Route Des Dolines
Sophia Antipolis, Cedex, 06921
1. LICOX Combined Oxygen and Temperature Probe, CC1.P1 - Electrode, ion selective, oxygen
Single Device Product
30204 Electrode, ion selective, oxygen
The combined oxygen and temperature probe may be used for monitoring of oxygen partial pressure as
well as temperature in the cerebral white matter. The probe may be implanted after craniotomy through a
burr or drill hole at the margin of an existing bone flap. The oxygen sensing starts 4 to 6 mm from the tip of
the probe. The temperature sensing part starts 13 to 15 mm from the end of the probe's oxygen sensing
part. The system is designed for no more than five days of continuous monitoring
A flexible sensor probe that is part of the Licox Brain Oxygen Monitoring System measures intracranial
oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating
the perfusion status of cerebral tissue local to sensor placement. Licox System values are relative within
an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is
intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or
ischemia are a concern.
Nil variant (as 1 device)
No Specific Conditions included on Record
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