Ampule

Main information

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

Documents

Localization

  • Available in:
  • Ampule opener
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216523
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216523

Brand Promotions - Ampule opener

ARTG entry for

Medical Device Included Class 1

Sponsor

Brand Promotions

Postal Address

PO Box 6291,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

24/10/2013

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

Apple Creative Products Inc

8F No 12 Lane 609 Chong Shin Road Section 5

New Taipei, , 24159

Taiwan (Province of China)

Products

1. Ampule opener

Product Type

Single Device Product

Effective date

24/10/2013

GMDN

10098 Ampule opener

Intended purpose

An ampoule opener designed specifically to safely remove the protective sterile seal of a glass ampoule.

The device design includes a movable holder having a closed string attached and a receiving base to hold

the ampoule cap firmly to prevent sharp-related injuries that may be sustained by the user from inadvertent

contact with the sharp edges of the seal whilst being removed.

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 04:59:13 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