Scalpel

Main information

  • Trade name:
  • Scalpel, one-piece, single use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Scalpel, one-piece, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219558
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219558

Ansell Ltd T/A Ansell Healthcare - Scalpel, one-piece, single use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Ansell Ltd T/A Ansell Healthcare

Postal Address

GPO Box 772 H,MELBOURNE, VIC, 3001

Australia

ARTG Start Date

24/01/2014

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

Ansell Healthcare Europe NV

Boulevard International 55

, Brussels, B-1070

Belgium

Products

1. Scalpel, one-piece, single use

Product Type

Single Device Product

Effective date

24/01/2014

GMDN

47569 Scalpel, one-piece, single use

Intended purpose

A sterile surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable

component) used by a physician to manually cut or dissect tissue.

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 02.12.2017 at 04:36:57 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

15-1-2018

Medical Devices Safety Update, Volume 6, Number 1, January 2018

Medical Devices Safety Update, Volume 6, Number 1, January 2018

Inappropriate use of scalpel removers; ransomware named as 2018's 'top hazard'; joint registry data; recent safety alerts

Therapeutic Goods Administration - Australia

There are no news related to this product.