Australia TGA ARTG record

Suture/needle passer, single-use

Australia TGA ARTG Registered Device · Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes · Depuy Mitek (a Johnson & Johnson Company) · Class IIa · Started April 14, 2023

Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Suture/needle passer, single-use

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 14, 2023
Effective Date: April 14, 2023

Sponsor

Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Name: Depuy Mitek (a Johnson & Johnson Company)
Country: United States of America
Address: 325 Paramount Drive, Raynham, MA, 02767

Intended purpose

hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure, This is a single-use device.

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 sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy Mitek (a Johnson & Johnson Company) in United States of America. The device registration started on April 14, 2023.

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.