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Orthopaedic implant inserter/extractor, single-use - ARTG 461405

Access comprehensive regulatory information for Orthopaedic implant inserter/extractor, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 461405 and sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by DePuy Ireland UC in Ireland. The device registration started on August 29, 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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TGA ARTG Official Data
Class Is
ARTG 461405
Class Is
Orthopaedic implant inserter/extractor, single-use
ARTG ID: 461405
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Orthopaedic implant inserter/extractor, single-use
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Intended Purpose

A single use surgical instrument designed to insert or extract an implantable orthopedic device through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
461405
Start Date
August 29, 2024
Effective Date
August 29, 2024
Manufacturer
Country
Ireland
Address
Loughbeg Ringaskiddy, Co Cork