Bowl, general purpose, single-use

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Linear Medical Pty Ltd
Class:
Class 1
Authorization number:
290481

Read the complete document

Public Summary

Summary for ARTG Entry:

290481

Linear Medical Pty Ltd - Bowl, general purpose, single-use

ARTG entry for

Medical Device Included Class 1

Sponsor

Linear Medical Pty Ltd

Postal Address

Unit D,5 Jubilee Ave,Warriewood, NSW, 2102

Australia

ARTG Start Date

20/06/2017

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

Linear Healthcare Group

Level 5 Ocean Financial Centre 10 Collyer

Quay

, Singapore, 049315

Singapore

Products

1. Bowl, general purpose, single-use

Product Type

Single Device Product

Effective date

20/06/2017

GMDN

42891 Bowl, general purpose, single-use

Intended purpose

A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids,

carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter.

The design and shape can vary from round, oblong, deep or quite shallow. This disposable device will

typically be incinerated along with its contents if used for waste. 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 03.11.2017 at 03:57:04 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

Search alerts related to this product

Share this information