Suction

Main information

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

Documents

Localization

  • Available in:
  • Suction tip, fibreoptic illuminated, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221341
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221341

Mac Surgical - Suction tip, fibreoptic illuminated, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

Mac Surgical

Postal Address

6 Roger Street,BROOKVALE, NSW, 2100

Australia

ARTG Start Date

17/03/2014

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

Mac Surgical

6 Roger Street

BROOKVALE, NSW, 2100

Australia

Products

1. Suction tip, fibreoptic illuminated, reusable

Product Type

Single Device Product

Effective date

17/03/2014

GMDN

35528 Suction tip, fibreoptic illuminated, reusable

Intended purpose

GMDNS Definition : Suction tip, fibreoptic illuminated, reusable[35528]

--------------------------------------------------------------------------------

A device that attaches to a suction instrument to control and direct suction during a surgical procedure or

treatment. It will typically have a built-in fibreoptic light used to enhance visualization of the operative site.

It may have an additional irrigation capability, e.g. a double lumen. This is a reusable device.

Primary Code and Term

35528 - Suction tip, fibreoptic illuminated, reusable

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 01:25:25 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.