Australia TGA ARTG recordHydroMARK in flexible applicator - Marker, lesion localization, implantable
Australia TGA ARTG Registered Device · GRC Surgical Pty Ltd · Devicor Medical Products Inc · Class III · Started November 17, 2020
Good Name: GRC Surgical Pty Ltd - HydroMARK in flexible applicator - Marker, lesion localization, implantable
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- November 17, 2020
- Effective Date
- July 15, 2021
- Country
- United States of America
- Address
- Fifth Floor 300 E-Business Way, Cincinnati, OH, 45241
To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI. The HydroMARK Breast Biopsy Site Marker is made of a resorbable hydrogel that expands with fluid and is then resorbed. The hydrogel material is visible under ultrasound. Embedded in the hydrogel is a coiled metallic wire that will be permanently visible under x-ray and MRI when the hydrogel is resorbed. The marker is supplied pre-loaded in delivery systems designed to fit a number of probes and handpieces.
Access comprehensive regulatory information for HydroMARK in flexible applicator - Marker, lesion localization, implantable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by GRC Surgical Pty Ltd, manufactured by Devicor Medical Products Inc in United States of America. The device registration started on November 17, 2020.
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.