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Endoscopic electrosurgical electrode, bipolar, single-use - ARTG 448117

Access comprehensive regulatory information for Endoscopic electrosurgical electrode, bipolar, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 448117 and sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Cardiovascular Systems Corporation in United States of America. The device registration started on May 08, 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 IIb
ARTG 448117
Class IIb
Endoscopic electrosurgical electrode, bipolar, single-use
ARTG ID: 448117
Good Name: Terumo Australia Pty Ltd - Endoscopic electrosurgical electrode, bipolar, single-use
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Intended Purpose

The VirtuoSaph Plus Endoscopic Vessel Harvesting (EVH) System is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is indicated for adult patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery and peripheral artery bypass. The radial artery is only used for coronary artery bypass.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
448117
Start Date
May 08, 2024
Effective Date
May 08, 2024
Manufacturer
Country
United States of America
Address
125 Blue Ball Road, Elkton, Maryland, 21921