Foetal

Main information

  • Trade name:
  • Foetal membrane manipulator
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Foetal membrane manipulator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218975
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218975

Endotherapeutics Pty Ltd - Foetal membrane manipulator

ARTG entry for

Medical Device Included Class Is

Sponsor

Endotherapeutics Pty Ltd

Postal Address

PO Box 673,EPPING, NSW, 1710

Australia

ARTG Start Date

7/01/2014

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

Yushin Medical Co Ltd

36 Jomaru-ro 427beon-gil Wonmi-gu

Bucheon-si, Gyeonggi-do, 420837

Korea - Republic of

Products

1. Foetal membrane manipulator

Product Type

Procedure Pack

Effective date

7/01/2014

GMDN

47978 Foetal membrane manipulator

Intended purpose

A sterile device used to atraumatically mechanically push and position an exposed or prolapsed foetal

membrane secondary to an incompetent cervix back through the cervical canal and into the uterus to

facilitate the surgical placement of a cervical cerclage in order to prolong pregnancy to a successful live

delivery. 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 10.11.2017 at 08:51:34 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