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Non-implantable needle guide, single-use

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 sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Aspen Surgical Products Inc in United States of America. The device registration started on September 06, 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 Is
Class Is
Non-implantable needle guide, single-use
Australia TGA ARTG Registered Device
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Non-implantable needle guide, single-use
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Intended Purpose

A sterile device designed intended for guiding a needle or catheter during a diagnostic ultrasound/imaging procedure to perform a precise needle placement to an anatomical target of the human body, at specific depths. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 06, 2023
Effective Date
September 06, 2023
Manufacturer
Country
United States of America
Address
6945 Southbelt Drive SE, Caledonia, MI, 49316