Summary for ARTG Entry:
Integra Neurosciences Pty Ltd - LICOX Complete Brain Tunneling Probe Kit, IT2 - Surgical procedure kit,
neurosurgical, single-use, non-medicated
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 Complete Brain Tunneling Probe Kit, IT2 - Surgical procedure kit, neurosurgical, single-use,
Medical device system
44063 Surgical procedure kit, neurosurgical, single-use, non-medicated
The kit consists of a parenteral probe guide with integral trocar Ref VK5.2 and combined oxygen and
temperature probe Ref CC1.P1. The parenteral probe guide, a small diameter plastic tube with attached
trocar, is designed to be "tunneled" under the scalp and provides fixation for the CC1.P1 probe. The probe
may be implanted after craniotomy through a burr or drill hole at the margin of an existing bone flap. The
system is designed for no more than five days of continuous monitoring.
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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