Laryngoscope

Main information

  • Trade name:
  • Laryngoscope handle, reusable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Laryngoscope handle, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221566
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221566

Karl Storz Endoscopy Australia Pty Ltd - Laryngoscope handle, reusable

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

23/03/2014

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 handle, reusable

Product Type

Single Device Product

Effective date

23/03/2014

GMDN

46830 Laryngoscope handle, reusable

Intended purpose

The hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the

laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the

batteries that provide energy for the airway-illuminating lighting of the laryngoscope (e.g., small light bulb

or fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic

resonance imaging (MRI) compatible. This is a reusable 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 12:39:12 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