MedGyn

Main information

  • Trade name:
  • MedGyn Cryotherapy System - Cryosurgical unit, general-purpose
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • MedGyn Cryotherapy System - Cryosurgical unit, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219261
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219261

Medical Industries Australia - MedGyn Cryotherapy System - Cryosurgical unit, general-purpose

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medical Industries Australia

Postal Address

512 Creek Street,ALBURY, NSW, 2640

Australia

ARTG Start Date

15/01/2014

Product category

Medical Device Class IIa

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

Medgyn Products Inc

100 W Industrial Rd

Addison, ILLINOIS, 60101

United States Of America

Products

1. MedGyn Cryotherapy System - Cryosurgical unit, general-purpose

Product Type

Medical device system

Effective date

15/01/2014

GMDN

11067 Cryosurgical unit, general-purpose

Intended purpose

This is a device that is intended to be used for all cryogenic procedures. It utilises liquid or gaseous

refrigerant to withdraw heat through direct application of cryogen or the cryogen cooled probe. This device

has applications for Dermatology, oral surgery, gynaecology, urology, otolaryngology or proctology.

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 08:03:58 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