Training model, anatomical,

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

Buy It Now

Available from:
3DMorphic Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
322870

Public Summary

Summary for ARTG Entry:

322870

3DMorphic Pty Ltd - Training model, anatomical, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

3DMorphic Pty Ltd

Postal Address

Unit 1 38 Raymond Avenue,Matraville, NSW, 2036

Australia

ARTG Start Date

9/09/2019

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

3DMorphic Pty Ltd

Unit 1 38 Raymond Avenue

Matraville, NSW, 2036

Australia

Products

1. Training model, anatomical, <specify>

Product Type

Single Device Product

Effective date

9/09/2019

GMDN

15811 Training model, anatomical, <specify>

Intended purpose

Anatomical models to assist surgeons with pre operative planning.

Improve and simplify the performance of surgical interventions by acting as an aid or reference to

elaborate a pre-operative surgical plan, to transfer the plan to surgery and to determine the correct sizing

of the fixture(s) eventually required as part of the surgical procedure.

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 04:45:33 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

Search alerts related to this product

Share this information