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Gouge, surgical - ARTG 482050

Access comprehensive regulatory information for Gouge, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482050 and sponsored by Joy Surgical Pty Ltd, manufactured by Tontarra Medizintechnik GmbH in Germany. The device registration started on March 07, 2025.

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 482050
Class I
Gouge, surgical
ARTG ID: 482050
Good Name: Joy Surgical Pty Ltd - Gouge, surgical
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Intended Purpose

Surgical gouge. A heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482050
Start Date
March 07, 2025
Effective Date
March 07, 2025
Manufacturer
Country
Germany
Address
Daimlerstrasse 15, Wurmlingen, D-78573