Laryngoscope

Main information

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

Documents

Localization

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

Other information

Status

  • 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:

221451

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

ARTG entry for

Medical Device Included Class 1

Sponsor

Karl Storz Endoscopy Australia Pty Ltd

Postal Address

PO Box 50,LANE COVE, NSW, 1595

Australia

ARTG Start Date

19/03/2014

Product category

Medical Device Class 1

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. Laryngoscope Blade, Rigid, Single Use

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information