Premicron

Main information

  • Trade name:
  • Premicron - Suture, polyester
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Premicron - Suture, polyester
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222737
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222737

B Braun Australia Pty Ltd - Premicron - Suture, polyester

ARTG entry for

Medical Device Included Class III

Sponsor

B Braun Australia Pty Ltd

Postal Address

PO Box 6221,BAULKHAM HILLS DC, NSW, 2153

Australia

ARTG Start Date

23/04/2014

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

B Braun Surgical SA

Carretera De Terassa 121

RUBI (BARCELONA), , E-08191

Spain

Products

1. Premicron - Suture, polyester

Product Type

Single Device Product

Effective date

23/04/2014

GMDN

13906 Suture, polyester

Functional description

Premicron is a non?absorbable braided and coated synthetic multifilament composed of polyester

fibres.Premicron sutures are coated uniformly with silicone to increase surface lubricity, thereby

enhancing handling characteristics.

Intended purpose

A non-absorbable, coated suture indicated for use in general surgery, cardiovascular, and vascular

indications.

Variant information

Suture, needle, physical attributes progressive curve

Suture, needle, physical attributes ski

Suture, needle, physical attributes hook

Suture, needle, physical attributes 1/2

Suture, needle, physical attributes 1/4

Length (cm) 20 to 250

Quantity/pack 6 to 36

Suture, pledgets 30 to 250

Suture, pledgets 3 to 6

Suture, gauge 6/0 to 5 USP

Suture, colour Green or white

Suture, needle, physical attributes lancet

Suture, needle, physical attributes heavy bodied

needle

Suture, needle, physical attributes 5/8

Suture, needle, physical attributes 3/8

Suture, needle, physical attributes sternum point

Suture, needle, physical attributes precision point

Suture, needle, physical attributes micropoint

Suture, needle, physical attributes trocar point

Suture, needle, physical attributes short cutting point

Suture, needle, physical attributes straight needle

Suture, needle, physical attributes cutting needle

Suture, needle, physical attributes round body

Specific Conditions

No Specific Conditions included on Record

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:23:42 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

© 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 22.11.2017 at 11:23:42 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