Depressor

Main information

  • Trade name:
  • Depressor, tongue
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Depressor, tongue
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219992
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219992

Alpha Medical Solutions - Depressor, tongue

ARTG entry for

Medical Device Included Class 1

Sponsor

Alpha Medical Solutions

Postal Address

Unit 508,17-19 Memorial Avenue,ST IVES, NSW, 2075

Australia

ARTG Start Date

8/02/2014

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

Agaplastic

Rua Cuba 353 Penha

CEP, Rio de Laneiro, 21020-160

Brazil

Products

1. Depressor, tongue

Product Type

Single Device Product

Effective date

8/02/2014

GMDN

14066 Depressor, tongue

Intended purpose

A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/ tissues

made of plastic. It may be aromatic/ flavoured to make them less intrusive. The device may be used in a

healthcare facility, doctor's office, or in the home. 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 05:45:26 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