Skin Stapler

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

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Available from:
Koala Medical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
321639

Public Summary

Summary for ARTG Entry:

321639

Koala Medical Pty Ltd - Skin Stapler

ARTG entry for

Medical Device Included Class IIa

Sponsor

Koala Medical Pty Ltd

Postal Address

PO Box 1191,MONA VALE, NSW, 2103

Australia

ARTG Start Date

12/08/2019

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

Xi'an Kaydee Medical Appliances Co Ltd

10101 Building 6 No 299 Second Industrial

Road

Space Base, Xian, 710100

China

Products

1. Skin Stapler

Product Type

Single Device Product

Effective date

12/08/2019

GMDN

46332 Skin Stapler

Intended purpose

A sterile hand-held surgical instrument designed for the application of skin staples to approximate free

edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with

staples and is intended to mechanically deliver staples with manual power. This is a single-use device.

Specific Conditions

© 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 02.11.2019 at 07:11:14 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

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