Ureterorendoscope

Main information

  • Trade name:
  • Ureterorendoscope, flexible, video
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ureterorendoscope, flexible, video
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219225
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219225

Karl Storz Endoscopy Australia Pty Ltd - Ureterorendoscope, flexible, video

ARTG entry for

Medical Device Included Class IIa

Sponsor

Karl Storz Endoscopy Australia Pty Ltd

Postal Address

PO Box 50,LANE COVE, NSW, 1595

Australia

ARTG Start Date

14/01/2014

Product category

Medical Device Class IIa

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

Karl Storz GmbH & Co KG

Mittelstrasse 8

TUTTLINGEN, Tuttlingen, D 78532

Germany

Products

1. Ureterorendoscope, flexible, video

Product Type

Medical device system

Effective date

14/01/2014

GMDN

38703 Ureterorendoscope, flexible, video

Intended purpose

The Uretero-Reno videoscope is intended to be used for visual examination, diagnosis and treatment of

the ureter and renal pelvis via the external urethral orifice. Its insertion portion is flexible. The image

transmitting system is a videoscope with a charge-coupled device (CDD) chip at the distal end.

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 08:11:12 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