Intrauterine

Main information

  • Trade name:
  • Intrauterine catheterization kit
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Intrauterine catheterization kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218159
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218159

Gytech Pty Ltd - Intrauterine catheterization kit

ARTG entry for

Medical Device Included Class Is

Sponsor

Gytech Pty Ltd

Postal Address

PO Box 76,ARMADALE NORTH, VIC, 3143

Australia

ARTG Start Date

5/12/2013

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

Catheter Research Inc

5610 West 82nd Street

Indianapolis, IN, 46278

United States Of America

Products

1. Intrauterine catheterization kit

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

37551 Intrauterine catheterization kit

Intended purpose

For administering contrast media or saline during Hysterosalpingography and Sonohysterography

procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening,

and/or patency of fallopian tubes.

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 11:36:44 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