Keratome

Main information

  • Trade name:
  • Keratome blade, single-use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Keratome blade, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217114
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217114

Spectrum Surgical Pty Ltd - Keratome blade, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Spectrum Surgical Pty Ltd

Postal Address

Suite 44 Building 4 / 195 Wellington Road,CLAYTON, VIC, 3168

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

Med-Logics Inc

Suite 102 / 26061 Merit Circle

Laguna Hills, CA, 92653

United States Of America

Products

1. Keratome blade, single-use

Product Type

Single Device Product

Effective date

12/11/2013

GMDN

44722 Keratome blade, single-use

Intended purpose

A single use thin blade mounted in a keratome to shave tissue from sections of the corneal lamellar.

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 03:20:07 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