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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 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.

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TGA ARTG Official Data
Class IIa
Class IIa
Suture/needle passer, single-use
Australia TGA ARTG Registered Device
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Suture/needle passer, single-use
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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.

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
Manufacturer
Country
United States of America
Address
325 Paramount Drive, Raynham, MA, 02767