Sealing

Main information

  • Trade name:
  • Sealing Unit - Sealing unit, packaging
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Sealing Unit - Sealing unit, packaging
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212502
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212502

Babich Maintenance & Steriliser Services Pty Ltd - Sealing Unit - Sealing unit, packaging

ARTG entry for

Other Therapeutic Good - Listed other

Sponsor

Babich Maintenance & Steriliser Services Pty Ltd

Postal Address

PO Box 3480,SUCCESS, WA, 6964

Australia

ARTG Start Date

23/07/2013

Product category

Other Therapeutic Good

Status

Active

Approval area

Medical Devices

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Sealing Unit - Sealing unit, packaging

Product Type

Single Device Product

Effective date

23/07/2013

GMDN

36674 Sealing unit, packaging

Intended purpose

Electrically heated laminate pouch and bag sealer, used for the sealing of laminated pouches and bags

containing clean non sterile surgical instruments prior to the sterilisation process. Post sterilisation the

surgical instruments contained within the pouches and bags are maintained in a sterile state ready for

transportation both internal and external for use in medical / surgical proceedures. Expiry of the product

contained in the pouches and bags is dependant on suitable storage and hospital policy.

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 11.11.2017 at 04:32:03 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