Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
A & D Surgical Solutions - Knife, ophthalmic
ARTG entry for
Medical Device Included Class 1
A & D Surgical Solutions
551 Tarneit Road,Hoppers Crossing, VIC, 3029
ARTG Start Date
Medical Device Class 1
- 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
Single Device Product
32764 Knife, ophthalmic
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.
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.
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.
Visit www.tga.gov.au for contact information