Uterine manipulator

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

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Available from:
The O R Company Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
293305

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Public Summary

Summary for ARTG Entry:

293305

The O R Company Pty Ltd - Uterine manipulator

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

The O R Company Pty Ltd

Postal Address

1/32 Silkwood Rise,Carrum Downs, VIC, 3201

Australia

ARTG Start Date

29/08/2017

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

Panpac Medical Corporation

6F-2 No 202 Sec 3 Ta-Tong Road

Shi-Chin District, New Taipei City, 221

Taiwan (Province of China)

Products

1. Uterine manipulator

Product Type

Single Device Product

Effective date

29/08/2017

GMDN

58051 Uterine manipulator

Intended purpose

Use of the Panpac Uterine Manipulator is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility

Exams, and Salpingoplastic procedures where manipulation of the uterus is required.

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 01.12.2017 at 06:52:09 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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