Trocar

Main information

  • Trade name:
  • Trocar sleeve seal/port reducer
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Trocar sleeve seal/port reducer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216826
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216826

Hologic Australia Pty Ltd - Trocar sleeve seal/port reducer

ARTG entry for

Medical Device Included Class Is

Sponsor

Hologic Australia Pty Ltd

Postal Address

PO Box 1971,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

1/11/2013

Product category

Medical Device Class Is

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

Hologic Inc

250 Campus Drive

Marlborough, MA, 01752

United States Of America

Products

1. Trocar sleeve seal/port reducer

Product Type

Single Device Product

Effective date

1/11/2013

GMDN

45597 Trocar sleeve seal/port reducer

Intended purpose

Seal to inhibit the leakage of the insufflation media (fluid) in both Hysteroscope & outflow working channels

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 04:08:35 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

15-11-2018

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