Bag

Main information

  • Trade name:
  • Bag, tissue extraction
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bag, tissue extraction
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217082
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217082

Life Healthcare Pty Ltd - Bag, tissue extraction

ARTG entry for

Medical Device Included Class IIa

Sponsor

Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

11/11/2013

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

Advanced Medical Design International LLC

10F-2 No 2 Fusing N Road

Taipei, , 104

Taiwan (Province of China)

Products

1. Bag, tissue extraction

Product Type

Single Device Product

Effective date

11/11/2013

GMDN

45130 Bag, tissue extraction

Intended purpose

The Lap Bag with Introducer, Auto-Retrieval system has applications in minimally invasive abdominal

procedures for the safe, convenient removal of tissue specimens such as the appendix, gallbladder,

gallstones, lymph nodes, an ectopic pregnancy, ovaries, small sections of bowel and other tissue

structures.

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 03:26:22 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

23-3-2019

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

19-7-2018

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Health Canada

22-6-2018

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Therapeutic Goods Administration - Australia

1-6-2018

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FDA - U.S. Food and Drug Administration

1-6-2018

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FDA - U.S. Food and Drug Administration

19-5-2018

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FDA - U.S. Food and Drug Administration

4-2-2019

On January 28th, @US_FDA  identified a Class I Recall, the most serious  type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid  Transfer Systems Due to Potential Malfunctions. Find out more about the recall here:  https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEXHM  #FDA #MedicalDevice pic.twitter.com/0l5O1bSaUy

FDA - U.S. Food and Drug Administration

30-5-2018

AUBAGIO (Sanofi-Aventis groupe)

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Europe -DG Health and Food Safety