Bone tap

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

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Available from:
ACRA Regulatory Services Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
339817

Public Summary

Summary for ARTG Entry:

339817

ACRA Regulatory Services Pty Ltd - Bone tap

ARTG entry for

Medical Device Included Class IIa

Sponsor

ACRA Regulatory Services Pty Ltd

Postal Address

7/84 Poincina Avenue, Tewantin, QLD, 4565

Australia

ARTG Start Date

20/07/2020

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

Tyber Medical

83 South Commerce Way Suite 310

Bethlehem, Pennsylvania, 18017

United States Of America

Products

1 . Bone tap

Product Type

Single Device Product

Effective Date

20/07/2020

GMDN

17507 Bone tap

Intended Purpose

Surgical instrument intended to be used during implantation of an orthopaedic prosthesis. This is a single use device intended to be

sterilized prior to use.

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 08:22:49 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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