Epidural

Main information

  • Trade name:
  • Epidural needle, non-threaded
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Epidural needle, non-threaded
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222450
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222450

Paragon Medical Pty Ltd - Epidural needle, non-threaded

ARTG entry for

Medical Device Included Class IIa

Sponsor

Paragon Medical Pty Ltd

Postal Address

PO Box 1964,Scoresby, VIC, 3179

Australia

ARTG Start Date

14/04/2014

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

Aspen Medical Europe Ltd

27 Thornhill Road North Moons Moat

Redditch, , B98 9NL

Products

1. Epidural needle, non-threaded

Product Type

Single Device Product

Effective date

14/04/2014

GMDN

58293 Epidural needle, non-threaded

Intended purpose

A sterile single use medical device used to deliver fluids or introduce a dedicated catheter into a patients

epidural space.

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 09.11.2017 at 09:33:58 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