Corneal marker

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

Buy It Now

Available from:
Wise Medics Limited
Class:
Class 1
Authorization status:
Included
Authorization number:
293881

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Public Summary

Summary for ARTG Entry:

293881

A & D Surgical Solutions - Corneal marker

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

15/09/2017

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. Corneal marker

Product Type

Single Device Product

Effective date

15/09/2017

GMDN

37896 Corneal marker

Intended purpose

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.

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 07:26:03 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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