Australia TGA ARTG record

Surgical stainless steel suture, monofilament

Australia TGA ARTG Registered Device · Avacare Australia Pty Ltd · DemeTECH Corp · Class IIb · Started October 21, 2021

Good Name: Avacare Australia Pty Ltd - Surgical stainless steel suture, monofilament

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 21, 2021
Effective Date: October 21, 2021

Sponsor

Name: Avacare Australia Pty Ltd

Manufacturer

Name: DemeTECH Corp
Country: United States of America
Address: 14175 NW 60th Avenue, Miami Lakes, FL, 33014

Intended purpose

DemeSTEEL is a stainless steel suture composed of 316L stainless steel, is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.

About this record

Access comprehensive regulatory information for Surgical stainless steel suture, monofilament in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Avacare Australia Pty Ltd, manufactured by DemeTECH Corp in United States of America. The device registration started on October 21, 2021.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.