Skin cleanser

Public Summary

Summary for ARTG Entry:

323761

NOVABAY PHARMACEUTICALS PTY LTD - Skin cleanser

ARTG entry for

Medical Device Included Class 1

Sponsor

NOVABAY PHARMACEUTICALS PTY LTD

Postal Address

2/44 Franklin Road,Doncaster East, VIC, 3109

Australia

ARTG Start Date

18/09/2019

Product category

Medical Device Class 1

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

NovaBay Pharmaceuticals Inc

2000 Powell Street Suite 1150

Emeryville, CA, 94608

United States Of America

Products

1. Skin cleanser

Product Type

Single Device Product

Effective date

18/09/2019

GMDN

46205 Skin cleanser

Intended purpose

Intended for cleaning eyelids and eyelashes to reduce and manage microorganisms and bacteria that may

contribute to conditions such as MGD, dry eye and blepharitis.

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

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Produced at 08.11.2019 at 10:21:45 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