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Ophthalmic knife, single-use - ARTG 395673

Access comprehensive regulatory information for Ophthalmic knife, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 395673 and sponsored by IQ Medical, manufactured by Microsurgical Technology Inc in United States of America. The device registration started on September 08, 2022.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIa
ARTG 395673
Class IIa
Ophthalmic knife, single-use
ARTG ID: 395673
Good Name: IQ Medical - Ophthalmic knife, single-use
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Intended Purpose

The TrabEx is a single-use manual ophthalmic surgical instrument intended to remove a strip of the Trabecular Meshwork for the management of infantile and adult glaucoma. This is achieved by improving Intraocular Pressure (IOP) through surgically removing a strip of the trabecular meshwork through hand-controlled excision, allowing for exposure of collector channels so the ocular humor can then flow through those collector channels. It is designed as a one-piece instrument with a sharp, trapezoidal single-edged or double-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, and be either single our dual-bladed at the distal end.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
395673
Start Date
September 08, 2022
Effective Date
September 08, 2022
Sponsor
Manufacturer
Country
United States of America
Address
8415 154Th Avenue Ne, Redmond, REDMOND, Washington, 98052