Open-surgery

Main information

  • Trade name:
  • Open-surgery electrosurgical forceps, single-use
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Open-surgery electrosurgical forceps, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221489
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221489

Jensen Instrument Technologies - Open-surgery electrosurgical forceps, single-use

ARTG entry for

Medical Device Included Class IIb

Sponsor

Jensen Instrument Technologies

Postal Address

PO Box 7180,NEW ENGLAND MC, NSW, 2348

Australia

ARTG Start Date

20/03/2014

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

Tecno Instruments Pvt Ltd

316-C Small Industrial Estate

Sialkot, Sialkot, 51340

Pakistan

Products

1. Open-surgery electrosurgical forceps, single-use

Product Type

Single Device Product

Effective date

20/03/2014

GMDN

56296 Open-surgery electrosurgical forceps, single-use

Intended purpose

Intended to be used in open surgery to cauterise vessels and tissue in open surgical procedures. These

forceps are available in bipolar and monopolar functions. Forceps are supplied complete with cable.

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 12:53:55 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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Scientific guideline:  Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

Scientific guideline: Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open

The main aim of the guideline is to outline the information which should be included for the adjuvant in the marketing authorisation application (MAA) of an immunological veterinary medicinal product (IVMP). This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’. The guideline discusses the important aspects to consider for the adjuvant in an IVMP and provides guidance on the information on the adjuvant which should be included in Parts 2, 3 and 4 of the MAA. The d...

Europe - EMA - European Medicines Agency

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

13-6-2018

Scientific guideline:  Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2), adopted in 2011 and in force since 2012 and the addendum ...

Europe - EMA - European Medicines Agency

4-6-2018

Consultation: Proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard

Consultation: Proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard

Consultation on the proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard is now open.

Therapeutic Goods Administration - Australia

29-5-2018

FDA Open Docket now available for feedback on benefits and risks of software that are not devices-  https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA Open Docket now available for feedback on benefits and risks of software that are not devices- https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA Open Docket now available for feedback on benefits and risks of software that are not devices- https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA - U.S. Food and Drug Administration