Main information

  • Trade name:
  • Injector, uterine
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Injector, uterine
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218156
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Gytech Pty Ltd - Injector, uterine

ARTG entry for

Medical Device Included Class Is


Gytech Pty Ltd

Postal Address



ARTG Start Date


Product category

Medical Device Class Is



Approval area

Medical Devices


- 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.




Catheter Research Inc

5610 West 82nd Street

Indianapolis, IN, 46278

United States Of America


1. Injector, uterine

Product Type

Single Device Product

Effective date



15622 Injector, uterine

Intended purpose

This is a sterile disposable device designed with a single lumen for injection of fluid through a distal tip. It is

indicated for such procedures as Sonohysterography. It is designed for "in office use." This device can be

applied without cervical dilation or anesthesia if the uterus can be sounded easily with a standard uterine

sound. The device provides for efficient sealing of the cervix when injections of liquid are required. The

product is slightly curved to facilitate easy entrance to the cervical canal.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 11:37:34 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 for contact information


EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

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Therapeutic Goods Administration - Australia


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MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.

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Withdrawal of a batch of EpiPen® 300 micrograms

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MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

There are no news related to this product.