Spring-loaded pneumoperitoneum needle, single-use

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

Buy It Now

Available from:
Optimed Technologies Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
293547

Read the complete document

Public Summary

Summary for ARTG Entry:

293547

Medical & Optical Instruments Australia Pty Ltd - Spring-loaded pneumoperitoneum needle, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medical & Optical Instruments Australia Pty Ltd

Postal Address

PO Box 850,ARTARMON, NSW, 1570

Australia

ARTG Start Date

5/09/2017

Product category

Medical Device Class IIa

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

Hangzhou Optcla Medical Instruments Co Ltd

No.2 Fengxiang Road Economic Development

Zone Tonglu Hangzhou

, Zhejiang, 311508

China

Products

1. Spring-loaded pneumoperitoneum needle, single-use

Product Type

Single Device Product

Effective date

5/09/2017

GMDN

12750 Spring-loaded pneumoperitoneum needle, single-use

Intended purpose

Spring loaded pneumoperitoneum needle single use item.

A slender metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or

surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of

insulflation to establish pneumoperitoneum prior to abdominal endoscopy.

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 04:13:39 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