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Non-implantable needle guide, single-use - ARTG 470208

Access comprehensive regulatory information for Non-implantable needle guide, 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 470208 and sponsored by Hologic (Australia & New Zealand) Pty Ltd, manufactured by Aspen Surgical Products Inc in United States of America. The device registration started on November 25, 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 Is
ARTG 470208
Class Is
Non-implantable needle guide, single-use
ARTG ID: 470208
Good Name: Hologic (Australia & New Zealand) Pty Ltd - Non-implantable needle guide, single-use
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Intended Purpose

An instrument designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. This guide is intended for guiding a biopsy needle when taking breast tissue biospies. It is supplied sterile and is single use.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
470208
Start Date
November 25, 2024
Effective Date
November 25, 2024
Manufacturer
Country
United States of America
Address
6945 Southbelt Drive SE, Caledonia, MI, 49316