Assisted

Main information

  • Trade name:
  • Assisted reproduction catheter set
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Assisted reproduction catheter set
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216400
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216400

Rocket Medical Pty Ltd - Assisted reproduction catheter set

ARTG entry for

Medical Device Included Class Is

Sponsor

Rocket Medical Pty Ltd

Postal Address

80 Kevin Avenue,AVALON BEACH, NSW, 2107

Australia

ARTG Start Date

23/10/2013

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

Rocket Medical Plc

Selding Road

Washington, Tyne and Wear, NE38-9BZ

Products

1. Assisted reproduction catheter set

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

41438 Assisted reproduction catheter set

Intended purpose

A collection of sterile devices used primarily to transfer gametes (eggs or sperm) and/or embryos into the

female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or

gamete intrafallopian transfer (GIFT)], a procedure that may be administered transvaginally or

laparoscopically

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 05:10:09 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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