Biatain Alginate Ag - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial

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

Buy It Now

Available from:
Coloplast Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
321707

Public Summary

Summary for ARTG Entry:

321707

Coloplast Pty Ltd - Biatain Alginate Ag - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial

ARTG entry for

Medical Device Included Class III

Sponsor

Coloplast Pty Ltd

Postal Address

PO Box 240,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

13/08/2019

Product category

Medical Device Class III

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

Advanced Medical Solutions Ltd

Premier Park 33 Road One Winsford Industrial

Estate

, Winsford Cheshire, CW7 3RT

United Kingdom

Products

1. Biatain Alginate Ag - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial

Product Type

Single Device Product

Effective date

13/08/2019

GMDN

47474 Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial

Functional description

Biatain Alginate Ag is a highly absorbent non-woven pad, composed of calcium alginate,

carboxy-methyl-cellulose, and an ionic silver compound. Silver ions are released in the presence of wound

fluid. As wound exudate is absorbed the alginate forms a gel, which aids autolytic debridement,

maintaining a moist environment for optimal wound healing. The gel ensures intact removal of the dressing

without damage to healing tissue. It can be used with a secondary dressing or under compression therapy.

Intended purpose

Biatain Alginate Ag is indicated for use in the management of the following moderate to heavily exuding

partial to full thickness wounds: post-operative wounds, trauma wounds (dermal lesions, trauma injuries or

incisions), leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites, cavity wounds, superficial and

partial thickness burns.

Variant information

Size (cm) 3x44

Size (cm) 30x20

Size (cm) 5x5

Size (cm) 10x10

Size (cm) 15x15

Specific Conditions

© 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 02.11.2019 at 07:02:10 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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