Surgical instrument cleaning adaptor

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

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Available from:
Life Systems Medical Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
293821

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Public Summary

Summary for ARTG Entry:

293821

Pacing Importers Pty Ltd - Surgical instrument cleaning adaptor

ARTG entry for

Medical Device Included Class 1

Sponsor

Pacing Importers Pty Ltd

Postal Address

188 Gladstone Street,South Melbourne, VIC, 3205

Australia

ARTG Start Date

13/09/2017

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

Atricure Inc

7555 Innovation Way

Mason, Ohio, 45040

United States Of America

Products

1. Surgical instrument cleaning adaptor

Product Type

Single Device Product

Effective date

13/09/2017

GMDN

60417 Surgical instrument cleaning adaptor

Intended purpose

A non-sterile device intended to connect the tubing of a device washer/decontaminator to the lumen of an

appropriate surgical instrument to facilitate an improved intraluminal flush of the instrument. It typically

consists of a tubing adaptor designed to fit a specific surgical instrument. This is a reusable device.

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 03:11:54 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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