Main information

  • Trade name:
  • Laryngoscope Blade, Rigid, Single Use
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Laryngoscope Blade, Rigid, Single Use
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221451
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Karl Storz Endoscopy Australia Pty Ltd - Laryngoscope Blade, Rigid, Single Use

ARTG entry for

Medical Device Included Class 1


Karl Storz Endoscopy Australia Pty Ltd

Postal Address

PO Box 50,LANE COVE, NSW, 1595


ARTG Start Date


Product category

Medical Device Class 1



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.




Karl Storz GmbH & Co KG

Mittelstrasse 8

TUTTLINGEN, Tuttlingen, D 78532



1. Laryngoscope Blade, Rigid, Single Use

Product Type

Single Device Product

Effective date



46828 Laryngoscope Blade, Rigid, Single Use

Intended purpose

The segment of a rigid laryngoscope that is inserted into the oral cavity to manipulate the tongue,

preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of

an endotracheal tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to

the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a

fibreoptic-light. This device may be curved or straight and of various designs and lengths; it may be

hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This

is a single-use device.

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 01:01:13 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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