Device Category Dossier

Marker, lesion localization, implantable

Device Category Dossier for Marker, lesion localization, implantable. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Breast biopsy site markers are implantable devices made of resorbable hydrogel with embedded metallic wire that expand with fluid and are then resorbed, remaining permanently visible under x-ray and MRI. They are used to mark tissue during percutaneous breast biopsy procedures, including axillary lymph nodes, and remain visible under ultrasound for at least six weeks.