Sigmoidoscope

Main information

  • Trade name:
  • Sigmoidoscope, rigid
  • Class:
  • Class Im
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sigmoidoscope, rigid
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217258
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217258

Horten Medical Pty Ltd - Sigmoidoscope, rigid

ARTG entry for

Medical Device Included Class Im

Sponsor

Horten Medical Pty Ltd

Postal Address

PO Box 3374,NORTH STRATHFIELD, NSW, 2137

Australia

ARTG Start Date

13/11/2013

Product category

Medical Device Class Im

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

Logikal Health Products Pty Ltd

Unit 3 18-20 Accolade Avenue

MORISSET, NSW, 2264

Australia

Products

1. Sigmoidoscope, rigid

Product Type

Single Device Product

Effective date

13/11/2013

GMDN

15058 Sigmoidoscope, rigid

Intended purpose

A rigid disposable sigmoidoscope used to visualise the rectum and sigmoid regions of the lower bowel.

This device incorporates a measuring scale on the barrel allowing an accurate estimate for penetration.

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 02:45:05 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