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Medical equipment drape, single-use - ARTG 398116

Access comprehensive regulatory information for Medical equipment drape, 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 398116 and sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Advance Medical Designs Inc in United States of America. The device registration started on October 20, 2022.

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 398116
Class Is
Medical equipment drape, single-use
ARTG ID: 398116
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Medical equipment drape, single-use
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Intended Purpose

A flexible polymer sheet designed to form a protective enclosure on or around a piece of medical equipment and/or equipment components. It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
398116
Start Date
October 20, 2022
Effective Date
October 20, 2022
Manufacturer
Country
United States of America
Address
1241 Atlanta Industrial Drive, Marietta, GEORGIA, 30066