Safil

Main information

  • Trade name:
  • Safil - Suture, polyglycolic acid
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Safil - Suture, polyglycolic acid
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222738
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222738

B Braun Australia Pty Ltd - Safil - Suture, polyglycolic acid

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. Safil - Suture, polyglycolic acid

Product Type

Single Device Product

Effective date

23/04/2014

GMDN

13908 Suture, polyglycolic acid

Functional description

Safil is a mid?term absorbable braided and coated synthetic suture made of pure polyglycolic acid. Safil

degrades by hydrolysis and provides predictable and reliable absorption.

Intended purpose

Safil is indicated for applications where surgical practice requires the use of synthetic, absorbable, braided

suture materials, particularly in the region of the gastro?intestinal tract, in gynaecology and urology and for

subcutaneous sutures and ligatures. Safil is also indicated for ophthalmology (e.g. strabismus operation)

and for microsurgery (e.g. peripheral nerve anastomosis and still growing tissues) if an absorbable suture

material is preferred.

Variant information

Suture, needle, physical attributes short cutting point

Suture, needle, physical attributes heavy bodied

needle

Suture, needle, physical attributes extra heavy

bodied needle

Suture, needle, physical attributes black needle

Suture, needle, physical attributes precision point

Suture, needle, physical attributes trocar point

Suture, colour undyed

Suture, colour violet

Suture, needle, physical attributes protection point

Suture, needle, physical attributes blunt point

Suture, needle, physical attributes micro-point

Suture, needle, physical attributes ski

Suture, needle, physical attributes progressive curved

Suture, needle, physical attributes straight

Suture, needle, physical attributes hook

Suture, needle, physical attributes cutting needle

Suture, needle, physical attributes round body

Suture, needle, physical attributes lancet needle

Suture, needle, physical attributes 1/2

Suture, needle, physical attributes 1/4

Suture, needle, physical attributes 5/8

Suture, needle, physical attributes 3/8

Suture, needle, physical attributes 1/8

Suture, colour violet

Quantity/pack 4 to 36

Suture, gauge 5 to 10/0 USP

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:23:24 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

Suture, no. of strands 1 to 12

Length (cm) 8 to 250 cm

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 2 of

Produced at 22.11.2017 at 11:23:24 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