Radiographic film processing chemical, manual

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Henry Schein Halas
Class:
Class 1
Authorization status:
Included
Authorization number:
324212

Public Summary

Summary for ARTG Entry:

324212

Henry Schein Halas - Radiographic film processing chemical, manual

ARTG entry for

Medical Device Included Class 1

Sponsor

Henry Schein Halas

Postal Address

Locked Bag 5003,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

30/09/2019

Product category

Medical Device Class 1

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

Carestream Health Inc

150 Verona Street

Rochester, New York, 14608

United States Of America

Products

1. Radiographic film processing chemical, manual

Product Type

Single Device Product

Effective date

30/09/2019

GMDN

41008 Radiographic film processing chemical, manual

Intended purpose

Photochemicals, e.g. a fixer / developer, for processing of images, x-ray film or other kinds of radiographic

film used in dental applications.

Specific Conditions

© 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 02.11.2019 at 03:24:38 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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