Australia flagARTG 445878

Suture/needle passer, single-use

ARTG ID: 445878 · The O R Company Pty Ltd · Aspen Surgical Products Inc · Class IIa · Started April 18, 2024

Good Name: The O R Company Pty Ltd - Suture/needle passer, single-use

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
445878
Start Date
April 18, 2024
Effective Date
April 18, 2024
Sponsor
Manufacturer
Country
United States of America
Address
6945 Southbelt Drive SE, Caledonia, MI, 49316
Intended purpose

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

About this record

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 registered under ARTG number 445878 and 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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