Pure Global

Suture/needle passer, single-use

Access comprehensive regulatory information for Suture/needle passer, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by The O R Company Pty Ltd, manufactured by Aspen Surgical Products Inc in United States of America. The device registration started on April 18, 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 IIa
Class IIa
Suture/needle passer, single-use
Australia TGA ARTG Registered Device
Good Name: The O R Company Pty Ltd - Suture/needle passer, single-use
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Intended Purpose

Intended to aid in the passing of sutures through bone and soft tissue during orthopedic surgery.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 18, 2024
Effective Date
April 18, 2024
Manufacturer
Country
United States of America
Address
6945 Southbelt Drive SE, Caledonia, MI, 49316