Monosyn

Main information

  • Trade name:
  • Monosyn Suture - Suture, polyglyconate
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Monosyn Suture - Suture, polyglyconate
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219424
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219424

B Braun Australia Pty Ltd - Monosyn Suture - Suture, polyglyconate

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

21/01/2014

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. Monosyn Suture - Suture, polyglyconate

Product Type

Single Device Product

Effective date

21/01/2014

GMDN

17246 Suture, polyglyconate

Functional description

Mid-term absorbable synthetic monofilament suture made of glyconate, available in undyed colour for the

closure of superficial wounds and in violet colour for the rest of indications. Monosyn offers excellent

handling properties and high knot security. Monosyn is recommended for all soft tissue approximations.

Intended purpose

Monosyn is indicated for use in general soft tissue approximation and/or ligation but not for use in

cardiovascular or neurological surgery. Typical applications are subcutaneous and intracutaneous sutures,

closing of episiotomy and gastro intestinal anastomosis.

Variant information

Suture, needle, physical attributes trocar point

Suture, needle, physical attributes round bodied

tappercutting needle

Suture, needle, physical attributes reverse cutting

needle

Suture, needle, physical attributes straight cutting

needle

Suture, needle, physical attributes straight round

bodied needle

Suture, needle, physical attributes round bodied ski

needle

Suture, needle, physical attributes round bodied

needle

Suture, needle, physical attributes 1/2 circle

Suture, needle, physical attributes 5/8 circle

Suture, needle, physical attributes 3/8 circle

Suture, no. of strands 1 to 6

Quantity/pack 4 to 36

Suture, gauge 7/0 to 2 (USP) or 0.5 to 5 mm

Suture, needle, physical attributes ski needle

Suture, needle, physical attributes progressive crved

Length (cm) 20 to 250

Suture, colour undyed

Suture, colour Violet

Suture, needle, physical attributes micropoint

Suture, needle, physical attributes protection point

Suture, needle, physical attributes blunt point

Specific Conditions

No Specific Conditions included on Record

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:35:43 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 11:35:43 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