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Surgical procedure kit, neurosurgical, single-use, non-medicated - ARTG 408471

Access comprehensive regulatory information for Surgical procedure kit, neurosurgical, single-use, non-medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 408471 and sponsored by Integra Neurosciences Pty Ltd, manufactured by Integra LifeSciences Switzerland Sarl in Switzerland. The device registration started on May 04, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class I
ARTG 408471
Class I
Surgical procedure kit, neurosurgical, single-use, non-medicated
ARTG ID: 408471
Good Name: Integra Neurosciences Pty Ltd - Surgical procedure kit, neurosurgical, single-use, non-medicated
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Intended Purpose

Two channel brain access system to be used as part of the Licox Brain Oxygen Monitoring System which 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.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General-Export
Registration Information
ARTG ID
408471
Start Date
May 04, 2023
Effective Date
May 04, 2023
Manufacturer
Country
Switzerland
Address
Floor 2 Rue Girardet 29, Le Locle, Switzerland, CH-2400