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Disposable Endoscopic Linear Cutter Stapler and Reloads - Endoscopic manual linear cutting stapler, single-use

Access comprehensive regulatory information for Disposable Endoscopic Linear Cutter Stapler and Reloads - Endoscopic manual linear cutting stapler, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Pure Sponsor Pty Ltd, manufactured by Fengh Medical Co Ltd in China. The device registration started on October 19, 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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Class IIb
Class IIb
Disposable Endoscopic Linear Cutter Stapler and Reloads - Endoscopic manual linear cutting stapler, single-use
Australia TGA ARTG Registered Device
Good Name: Pure Sponsor Pty Ltd - Disposable Endoscopic Linear Cutter Stapler and Reloads - Endoscopic manual linear cutting stapler, single-use
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DJ Fang

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Intended Purpose

The Disposable Endoscopic Linear Cutter Stapler and Reloads is intended for transection, resection and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It also can be used for the transection and resection of liver parenchyma (hepatic vasculature and biliary structure), pancreas, kidney and spleen. They can be used with staple line or tissue buttressing materials.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
October 19, 2021
Effective Date
October 19, 2021
Manufacturer
Country
China
Address
D3 No 6 Dongsheng West Road Jiangyin National High-Tech Zone, Jiangsu, 214437