Laparoscopic SUrgical Procedure Pack - Endo GIA - Surgical procedure kit, laparoscopic, single-use, non-medicated

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Medtronic Australasia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
324060

Public Summary

Summary for ARTG Entry:

324060

Medtronic Australasia Pty Ltd - Laparoscopic SUrgical Procedure Pack - Endo GIA - Surgical procedure kit,

laparoscopic, single-use, non-medicated

ARTG entry for

Medical Device Included Class III

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

26/09/2019

Product category

Medical Device Class III

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

Medtronic Australasia Pty Ltd

5 Alma Road

Macquarie Park, NSW, 2113

Australia

Products

1. Laparoscopic SUrgical Procedure Pack - Endo GIA - Surgical procedure kit, laparoscopic, single-use,

non-medicated

Product Type

Procedure Pack

Effective date

26/09/2019

GMDN

44096 Surgical procedure kit, laparoscopic, single-use, non-medicated

Functional description

The laparoscopic procedure pack includes stapler and the Endo GIA Reload with Tristaple Technology

that place two triple staggered rows of titanium staples, along with instrumentation for the surgical

procedure including trocars, cannulas, and retrieval pouch. The pack is available with or without anti-fog

solution. Endo GIA Reload with Tristaple Technology procedure packs will include at least 1 of either the

ENDO GIA TRISTAPLE 45 Vas/Med OR ENDO GIA TRISTAPLE 60 Vas/Med (and up to 5 of each).

Intended purpose

The laparoscopic procedure pack contains instruments to perform various surgical procedures in

abdominal, gynaecologic, paediatric and thoracic surgery for resection, transection and creation of

anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and

biliary structures.

Variant information

Model number (see guidance docs) EGIAUXL

Model number (see guidance docs) 176674P

Model number (see guidance docs) NONB15STF

Model number (see guidance docs) SIGTRS60AXT

Model number (see guidance docs) UNVCA12STF

Model number (see guidance docs) ONB12STF

Model number (see guidance docs) 220-50

Model number (see guidance docs) SIG30AVM

Model number (see guidance docs) LF1937

Model number (see guidance docs) 174301

Model number (see guidance docs) SIGTRS60AMT

Model number (see guidance docs) EGIA45AVM

Model number (see guidance docs) ONB5STF

Model number (see guidance docs) EGIAUSTND

Model number (see guidance docs) 174601

Model number (see guidance docs) E3773-45C

Model number (see guidance docs) LF1844

Model number (see guidance docs) SIG45AXT

Model number (see guidance docs) B12STS

Model number (see guidance docs) LF5644

Model number (see guidance docs) VS101005

Public Summary

Page 1 of

Produced at 02.11.2019 at 03:46:13 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

Model number (see guidance docs) VS101012P

Model number (see guidance docs) EGIA60CTAVM

Model number (see guidance docs) 176657

Model number (see guidance docs) S100000

Model number (see guidance docs) SCD391

Model number (see guidance docs) BPT12STS

Model number (see guidance docs) UNVCA5STF

Model number (see guidance docs) 173049

Model number (see guidance docs) 176674PF

Model number (see guidance docs) ONB5LGF

Model number (see guidance docs) ONB12LGF

Model number (see guidance docs) 21-345

Model number (see guidance docs) SIG60AXT

Model number (see guidance docs) EGIA60AMT

Model number (see guidance docs) LF1644

Model number (see guidance docs) LF1837

Model number (see guidance docs) ONB15STF

Specific Conditions

© 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 2 of

Produced at 02.11.2019 at 03:46:13 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

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