Laparoscopic grasping forceps, single-use

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

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written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

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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.

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