Surgical

Main information

  • Trade name:
  • Surgical procedure kit, ophthalmic, non-medicated, single-use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Surgical procedure kit, ophthalmic, non-medicated, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217143
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217143

Carl Zeiss Pty Ltd - Surgical procedure kit, ophthalmic, non-medicated, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Carl Zeiss Pty Ltd

Postal Address

PO Box 501,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

12/11/2013

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

Carl Zeiss Meditec AG

Goeschwitzer Strasse 51-52

Jena, , D-07745

Germany

Products

1. Surgical procedure kit, ophthalmic, non-medicated, single-use

Product Type

Procedure Pack

Effective date

12/11/2013

GMDN

45150 Surgical procedure kit, ophthalmic, non-medicated, single-use

Intended purpose

This single use device is an accessory for Carl Zeiss phaco systems. It has been designed to emulsify and

aspirate the eye lens during human cataract surgery.

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 10.11.2017 at 03:15:08 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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