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Orthopaedic cement dispensing gun - ARTG 474510

Access comprehensive regulatory information for Orthopaedic cement dispensing gun in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 474510 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Medtronic Sofamor Danek USA Inc in United States of America. The device registration started on December 23, 2024.

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 474510
Class I
Orthopaedic cement dispensing gun
ARTG ID: 474510
Good Name: Medtronic Australasia Pty Ltd - Orthopaedic cement dispensing gun
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Intended Purpose

An orthopedic manual surgical instrument intended for use in surgical procedures to hold an orthopedic cement syringe and to facilitate the dispensing of the cement in the syringe to the application site.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
474510
Start Date
December 23, 2024
Effective Date
December 23, 2024
Manufacturer
Country
United States of America
Address
1800 Pyramid Place, Memphis, Tennessee, 38132