Needle

Main information

  • Trade name:
  • Needle, aspirating, single use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Needle, aspirating, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220615
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220615

N Stenning & Co Pty Ltd - Needle, aspirating, single use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Getz Healthcare Pty Ltd

Postal Address

5 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

28/02/2014

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

Zamar D O O

Mate Vlasica 26 xyz

, Porec, 52440

Croatia

Products

1. Needle, aspirating, single use

Product Type

Single Device Product

Effective date

28/02/2014

GMDN

35886 Needle, aspirating, single use

Intended purpose

This drainage needle is intended for paracentesis/Thoracentesis (fluid removal for biopsy) procedures. It is

attached to a drainage bag to collect fluid from the site for collection for assessment. It is for use in the

surgical arena, not for long term drainage. It is supplied sterile and is single use.

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 01.12.2017 at 06:14:14 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

16-4-2018

Acupuncture needles with false CE marking

Acupuncture needles with false CE marking

Sterile acupuncture needles with false CE marking are sold online. We ask you to pay attention to these products because there is no documentation to support the product's sterility or the materials used to fabricate the device.

Danish Medicines Agency

27-9-2018

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1

FDA - U.S. Food and Drug Administration