Laparoscopic grasping forceps, single-use

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)

08-11-2019

제공처:
Big Green Surgical Company Pty Ltd
수업:
Class IIb
승인 상태:
Included
승인 번호:
323789

Public Summary

Summary for ARTG Entry:

323789

Big Green Surgical Company Pty Ltd - Laparoscopic grasping forceps, single-use

ARTG entry for

Medical Device Included Class IIb

Sponsor

Big Green Surgical Company Pty Ltd

Postal Address

46 Albert Street,PRESTON, VIC, 3072

Australia

ARTG Start Date

18/09/2019

Product category

Medical Device Class IIb

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

Microline Surgical Inc

50 Dunham Road Suite 1500

Beverly, Massachusetts, 01915

United States Of America

Products

1. Laparoscopic grasping forceps, single-use

Product Type

Single Device Product

Effective date

18/09/2019

GMDN

61839 Laparoscopic grasping forceps, single-use

Intended purpose

Tips intended for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic

surgical procedures.

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 1 of

Produced at 08.11.2019 at 10:17:19 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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