Suction

Main information

  • Trade name:
  • Suction tip,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Suction tip,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222741
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222741

NL-Tec Pty Ltd - Suction tip, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

NL-Tec Pty Ltd

Postal Address

PO Box 226,WILLETTON, WA, 6155

Australia

ARTG Start Date

23/04/2014

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

Bionix Development Corporation

5154 Enterprise Boulevard

Toledo, OH, 43612

United States Of America

Products

1. Suction tip, <specify>

Product Type

Single Device Product

Effective date

23/04/2014

GMDN

13848 Suction tip, <specify>

Intended purpose

The Lighted Suction is designed to remove soft, viscous cerumen or large plugs. Also effective for foreign

bodies with the addition of the silicon suction tip. Suction as a tool eliminates the top down sweeping

motion of a curettage procedure reducing the risk of trauma to the ear canal

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 09.11.2017 at 07:58:41 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

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

There are no news related to this product.