Topical

Main information

  • Trade name:
  • Topical plant polysaccharide haemostatic agent, non-bioabsorbable
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Topical plant polysaccharide haemostatic agent, non-bioabsorbable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218594
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218594

F A Ready Pty Ltd - Topical plant polysaccharide haemostatic agent, non-bioabsorbable

ARTG entry for

Medical Device Included Class IIa

Sponsor

F A Ready Pty Ltd

Postal Address

PO Box 2233,Marmion, WA, 6020

Australia

ARTG Start Date

16/12/2013

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

Hui Zhou Foryou Medical Devices Co Ltd

North Shangxia Road Dongjiang Hi-tech

Industry Park

, HuiZhou, 516005

China

Products

1. Topical plant polysaccharide haemostatic agent, non-bioabsorbable

Product Type

Single Device Product

Effective date

16/12/2013

GMDN

58059 Topical plant polysaccharide haemostatic agent, non-bioabsorbable

Intended purpose

Haemostatic Gauze for use in the control of disseminated haemorrhage, capillary and small vessels

haemorrhage when ligation, electrical coagulation or other conventional methods are impractical or

ineffective for the temporary control of bleeding wounds such as post-operative nasal cavity and paranasal

sinus bleeding, tooth extraction wounds, and topical bleeding of injured body surface.

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 23.11.2017 at 05:46:42 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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