Vascular catheter introduction needle

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Florey Medical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
292864

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Public Summary

Summary for ARTG Entry:

292864

Florey Medical Pty Ltd - Vascular catheter introduction needle

ARTG entry for

Medical Device Included Class IIa

Sponsor

Florey Medical Pty Ltd

Postal Address

33 Haig Street,Netherby, SA, 5062

Australia

ARTG Start Date

16/08/2017

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

Galt Medical Corp

2220 Merritt Drive

Garland, TX, 75041

United States Of America

Products

1. Vascular catheter introduction needle

Product Type

Single Device Product

Effective date

16/08/2017

GMDN

61502 Vascular catheter introduction needle

Intended purpose

Introducer needles are used for the percutaneous introduction of guidewires.

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 03.11.2017 at 06:52:54 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

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