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Suture/Needle Passer - Suture/needle passer, single-use - ARTG 447490

Access comprehensive regulatory information for Suture/Needle Passer - Suture/needle passer, 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 447490 and sponsored by Device Technologies Australia Pty Ltd, manufactured by LSI Solutions Inc in United States of America. The device registration started on May 01, 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 447490
Class Is
Suture/Needle Passer - Suture/needle passer, single-use
ARTG ID: 447490
Good Name: Device Technologies Australia Pty Ltd - Suture/Needle Passer - Suture/needle passer, single-use
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Intended Purpose

A non-invasive suture/needle passer system intended to drive sutures and suture needles through a prosthesis prior to implantation of the prosthesis. This system is not intended to drive sutures or suture needles through tissue.

Device Classification
Risk Class
Class Is
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
447490
Start Date
May 01, 2024
Effective Date
May 01, 2024
Manufacturer
Country
United States of America
Address
7796 Victor Mendon Road, VICTOR, NY, 14564