Custom-made anatomy model/surgical guide kit

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

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Available from:
Specifica Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
322576

Public Summary

Summary for ARTG Entry:

322576

Specifica Pty Ltd - Custom-made anatomy model/surgical guide kit

ARTG entry for

Medical Device Included Class 1

Sponsor

Specifica Pty Ltd

Postal Address

3/83 Connells Point Rd,South Hurstville, NSW, 2221

Australia

ARTG Start Date

2/09/2019

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

Specifica Pty Ltd

3/83 Connells Point Rd

South Hurstville, NSW, 2221

Australia

Products

1. Custom-made anatomy model/surgical guide kit

Product Type

Single Device Product

Effective date

2/09/2019

GMDN

62249 Custom-made anatomy model/surgical guide kit

Intended purpose

Guides and Biomodels manufactured by 3-D printing intended to assist in anatomical visualization, surgical

treatment planning, for intraoperative dental and craniomaxillofacial surgical procedures

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 05:26:33 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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