Main information

  • Trade name:
  • Camera accessory, surgical, holder
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Camera accessory, surgical, holder
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216759
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Getz Healthcare Pty Ltd - Camera accessory, surgical, holder

ARTG entry for

Medical Device Included Class Is


Getz Healthcare Pty Ltd

Postal Address

5 Orion Road,LANE COVE, NSW, 2066


ARTG Start Date


Product category

Medical Device Class Is



Approval area

Medical Devices


- 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.




Freehand 2010 Ltd

Unit 2 Weyvern Park Portsmouth Road

Peasmarsh, Guildford, GU 3 1NA


1. Camera accessory, surgical, holder

Product Type

Medical device system

Effective date



32288 Camera accessory, surgical, holder

Intended purpose

The Freehand is a camera holder that sits outside the sterile field and is intended for use in minimally

invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery where a rigid

laparoscope/endoscope is intended for use, and allows the surgeon directly to control movements of a

rigid endoscope by head movements.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 04:21:45 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.

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