Australia TGA ARTG record

Integra Brain Retractor System - Neurosurgical retraction system, brain

Australia TGA ARTG Registered Device · Integra Neurosciences Pty Ltd · Integra Lifesciences Corporation · Class IIa · Started May 27, 2022

Good Name: Integra Neurosciences Pty Ltd - Integra Brain Retractor System - Neurosurgical retraction system, brain

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: May 27, 2022
Effective Date: May 27, 2022

Sponsor

Name: Integra Neurosciences Pty Ltd

Manufacturer

Name: Integra Lifesciences Corporation
Country: United States of America
Address: 4900 Charlemar Drive Bldg A, Cincinnati, Ohio, 45227

Intended purpose

The Integra Brain Retractor System is indicated to construct a framework surrounding the operative site for the purposes of retracting tissue during neurosurgical procedures, and also serves to support and position various instruments and handrests.

About this record

Access comprehensive regulatory information for Integra Brain Retractor System - Neurosurgical retraction system, brain in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Integra Neurosciences Pty Ltd, manufactured by Integra Lifesciences Corporation in United States of America. The device registration started on May 27, 2022.

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.