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Surgical stainless steel suture, monofilament

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Surgical stainless steel suture, monofilament
Australia TGA ARTG Registered Device
Good Name: Avacare Australia Pty Ltd - Surgical stainless steel suture, monofilament
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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.

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
Manufacturer
Country
United States of America
Address
14175 NW 60th Avenue, Miami Lakes, FL, 33014