Knife, ophthalmic

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

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Wise Medics Limited
Class 1
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Public Summary

Summary for ARTG Entry:


A & D Surgical Solutions - Knife, ophthalmic

ARTG entry for

Medical Device Included Class 1


A & D Surgical Solutions

Postal Address

551 Tarneit Road,Hoppers Crossing, VIC, 3029


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Speedway Surgical Co

A-67/5 GT Karnal Road Industrial Area

New Delhi, North West Delhi, 110033



1. Knife, ophthalmic

Product Type

Single Device Product

Effective date



32764 Knife, ophthalmic

Intended purpose

A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and

surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a

sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of

blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision

cataract surgery). It is usually made of high-grade stainless steel or titanium and some types can employ

sapphire/diamond blades. 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

Public Summary

Page 1 of

Produced at 23.11.2017 at 07:26:35 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.

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