Suction

Main information

  • Trade name:
  • Suction system, surgical wound
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Suction system, surgical wound
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216706
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216706

Dentsply Sirona Pty Ltd - Suction system, surgical wound

ARTG entry for

Medical Device Included Class Is

Sponsor

Dentsply Sirona Pty Ltd

Postal Address

19 / 39 Herbert Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

30/10/2013

Product category

Medical Device Class Is

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

Innoventa Medica

Blokken 45

, Birkeroed, 3460

Denmark

Products

1. Suction system, surgical wound

Product Type

Single Device Product

Effective date

30/10/2013

GMDN

44810 Suction system, surgical wound

Intended purpose

The Seroma handset is for aspiration of fluid from a subdermal cavity, where more than 50 ml volume is

expected to be drained. Typical example is seroma aspiration after breast cancer surgery. The handset is

a single-use device and is to be used as part of a system with a needle and a vacuum bottle, both of which

are supplied separately.

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 19.10.2017 at 01:01:41 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.