Cannula, eye, irrigating/aspirating

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

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Available from:
Wise Medics Limited
Class:
Class 1
Authorization status:
Included
Authorization number:
293839

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Public Summary

Summary for ARTG Entry:

293839

A & D Surgical Solutions - Cannula, eye, irrigating/aspirating

ARTG entry for

Medical Device Included Class 1

Sponsor

A & D Surgical Solutions

Postal Address

551 Tarneit Road,Hoppers Crossing, VIC, 3029

Australia

ARTG Start Date

14/09/2017

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

Speedway Surgical Co

A-67/5 GT Karnal Road Industrial Area

New Delhi, North West Delhi, 110033

India

Products

1. Cannula, eye, irrigating/aspirating

Product Type

Single Device Product

Effective date

14/09/2017

GMDN

17899 Cannula, eye, irrigating/aspirating

Intended purpose

rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion,

irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification,

vitreoretinal surgery, sub-Tenon's anaesthesia, capsule polishing). It is a single- or dual-lumen device,

typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or

include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a

sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to

be sterilized prior to use.

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 07:28:21 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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