Bone punch, single-use

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)

01-11-2019

Dostopno od:
Smith & Nephew Pty Ltd
Razred:
Class IIa
Status dovoljenje:
Included
Številka dovoljenja:
322768

Public Summary

Summary for ARTG Entry:

322768

Smith & Nephew Pty Ltd - Bone punch, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Smith & Nephew Pty Ltd

Postal Address

PO Box 393, North Ryde, NSW, 1670

Australia

ARTG Start Date

6/09/2019

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

Smith & Nephew Inc

1450 Brooks Rd

Memphis, Tennessee, 38116

United States Of America

Products

1. Bone punch, single-use

Product Type

Single Device Product

Effective date

6/09/2019

GMDN

62612 Bone punch, single-use

Intended purpose

A single use surgical instrument intended to cut the bone to prepare the tibia to accept the tibia base

prosthesis.

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 04:59:51 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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