X-ray film, diagnostic imaging, dental, non-screen

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

Nopērc to tagad

Pieejams no:
Henry Schein Halas
Klase:
Class IIa
Autorizācija statuss:
Included
Autorizācija numurs:
324242

Public Summary

Summary for ARTG Entry:

324242

Henry Schein Halas - X-ray film, diagnostic imaging, dental, non-screen

ARTG entry for

Medical Device Included Class IIa

Sponsor

Henry Schein Halas

Postal Address

Locked Bag 5003,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

1/10/2019

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

Carestream Health Inc

150 Verona Street

Rochester, New York, 14608

United States Of America

Products

1. X-ray film, diagnostic imaging, dental, non-screen

Product Type

Single Device Product

Effective date

1/10/2019

GMDN

40978 X-ray film, diagnostic imaging, dental, non-screen

Intended purpose

These intraoral dental films are basically recording films that is used in dentistry. A non-screen x-ray film

specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to

x-rays and is relatively insensitive to the visible light emitted from screen

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 03:20:32 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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