Awl

Main information

  • Trade name:
  • Awl
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Awl
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220316
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220316

Jensen Instrument Technologies - Awl

ARTG entry for

Medical Device Included Class 1

Sponsor

Jensen Instrument Technologies

Postal Address

PO Box 7180,NEW ENGLAND MC, NSW, 2348

Australia

ARTG Start Date

20/02/2014

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

Jensen Instrument Technologies

39 Gunnedah Road

TAMWORTH, NSW, 2340

Australia

Products

1. Awl

Product Type

Single Device Product

Effective date

20/02/2014

GMDN

15275 Awl

Intended purpose

A spike-like, manual orthopaedic surgical instrument, lacking a blade, that is used to bore holes in bone.

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 10.11.2017 at 04:32:59 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

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

FDA - U.S. Food and Drug Administration

There are no news related to this product.