Universal

Main information

  • Trade name:
  • Universal electrosurgical diathermy system bipolar electrode, reusable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Universal electrosurgical diathermy system bipolar electrode, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218545
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218545

Life Healthcare Pty Ltd - Universal electrosurgical diathermy system bipolar electrode, reusable

ARTG entry for

Medical Device Included Class IIb

Sponsor

Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

13/12/2013

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

Boss Instruments Ltd

104 Sommerfield Drive

Gordonsville, VA, 22942

United States Of America

Products

1. Universal electrosurgical diathermy system bipolar electrode, reusable

Product Type

Single Device Product

Effective date

13/12/2013

GMDN

58465 Universal electrosurgical diathermy system bipolar electrode, reusable

Intended purpose

A bipolar metal tip that is attached to an electrosurgical diathermy handpiece and makes contact with a

patient in order to provide an electrical connection between the output terminals of an electrosurgical

diathermy generator and the patient. The emitted energy is used to develop heat in tissues for cutting and

coagulating during surgery.

Specific Conditions

No Specific Conditions included on Record

© 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 10.11.2017 at 10:07:15 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

7-11-2018

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