Clamp, table, operation

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

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Available from:
Kalaparna Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339659

Public Summary

Summary for ARTG Entry:

339659

Kalaparna Pty Ltd - Clamp, table, operation

ARTG entry for

Medical Device Included Class 1

Sponsor

Kalaparna Pty Ltd

Postal Address

PO Box 3265, Dural, NSW, 2158

Australia

ARTG Start Date

16/07/2020

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

TeDan Surgical Innovations LLC

12615 W Airport Boulevard Suite 200

Sugar Land, TX, 77478

United States Of America

Products

1 . Clamp, table, operation

Product Type

Single Device Product

Effective Date

16/07/2020

GMDN

37050 Clamp, table, operation

Intended Purpose

A device that is designed to hold different holding systems and accessories on to the operating table providing exact positioning

and stability. The clamp allows for easy and safe adjustments of the position of the devices and provides a secure locking

mechanism.

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 22.07.2020 at 08:50:09 AEST

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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