Open-surgery electrosurgical forceps, single-use

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Medtronic Australasia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
323696

Public Summary

Summary for ARTG Entry:

323696

Medtronic Australasia Pty Ltd - Open-surgery electrosurgical forceps, single-use

ARTG entry for

Medical Device Included Class IIb

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/09/2019

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Covidien llc

15 Hampshire Street

Mansfield, MA, 02048

United States Of America

Products

1. Open-surgery electrosurgical forceps, single-use

Product Type

Single Device Product

Effective date

17/09/2019

GMDN

56296 Open-surgery electrosurgical forceps, single-use

Intended purpose

The Bipolar Forceps are intended to be used for grasping, manipulating, and coagulating soft tissue during

general surgery.

They may be used with the Bipolar System for the treatment of symptomatic grade I and grade II internal

hemorrhoids.

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 08.11.2019 at 10:28:01 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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