Vitreous humour replacement medium rinsing solution.

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

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Available from:
IQ Medical
Class:
Class IIa
Authorization status:
Included
Authorization number:
324301

Public Summary

Summary for ARTG Entry:

324301

IQ Medical - Vitreous humour replacement medium rinsing solution.

ARTG entry for

Medical Device Included Class IIa

Sponsor

IQ Medical

Postal Address

2 / 86 Mary Street,UNLEY, SA, 5061

Australia

ARTG Start Date

2/10/2019

Product category

Medical Device Class IIa

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

Fluoron GmbH

Magirus-Deutz-Str 10

, Ulm, 89077

Germany

Products

1. Vitreous humour replacement medium rinsing solution.

Product Type

Single Device Product

Effective date

2/10/2019

GMDN

64238 Vitreous humour replacement medium rinsing solution.

Intended purpose

A liquid substance (semifluorinated alkane)intended for intraoperative use as a transient medium [rinsing

solution] to remove vitreous humour replacement medium residues (e.g., silicone oil residues) from the

vitreous chamber after long-term retinal tamponade; it may in addition be intended to be used as a

cleaning medium for an intraocular lens [IOL] following tamponade. It is intended to be injected into the

interior of the eye, and may be supplied in a prefilled syringe or other container. This is a single-use device

Specific Conditions

© 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 02.11.2019 at 03:11:54 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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