Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
A & D Surgical Solutions - Corneal marker
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. Corneal marker
Single Device Product
37896 Corneal marker
A manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an
ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long
slender handle with a distal end having characteristics for producing specific markings. The device may
have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking
wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to
transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and
horizontal points for precision alignment. This is a reusable device.
No Specific Conditions included on Record
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Produced at 23.11.2017 at 07:26:03 AEDT
This is not an ARTG Certificate document.
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