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Fascial tissue dilator, single-use - ARTG 375244

Access comprehensive regulatory information for Fascial tissue dilator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 375244 and sponsored by William A Cook Australia Pty Ltd, manufactured by Cook Vandergrift Inc in United States of America. The device registration started on September 24, 2021.

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
ARTG 375244
Class IIa
Fascial tissue dilator, single-use
ARTG ID: 375244
Good Name: William A Cook Australia Pty Ltd - Fascial tissue dilator, single-use
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Intended Purpose

The Curved 16 Fr Introducer Sheath Set โ€” Femoral is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
375244
Start Date
September 24, 2021
Effective Date
September 24, 2021
Manufacturer
Country
United States of America
Address
1186 Montgomery Lane, Vandergrift, Pennsylvania, 15690