Mask, surgical, single use

Public Summary

Summary for ARTG Entry:

339908

Pro-Tek Plastics Australia - Mask, surgical, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Pro-Tek Plastics Australia

Postal Address

PO Box 531, ELTHAM, VIC, 3095

Australia

ARTG Start Date

21/07/2020

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

Crown Name (WH) United Co Ltd

Changhang Building RM 1805 No 69 Yanjiang

Avenue

Wuhan, Hubei, 430021

China

Products

1 . Mask, surgical, single use

Product Type

Single Device Product

Effective Date

21/07/2020

GMDN

35177 Mask, surgical, single use

Intended Purpose

A single use device made from non woven fabrics which is placed over the nose and mouth by medical personnel to prevent the

transmission of air borne organisms while surgery is being performed.

Specific Conditions

No Specific Conditions included on Record

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Public Summary

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Produced at 22.07.2020 at 07:59:43 AEST

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.

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