Device Dossier
Marker, lesion localization, implantable
Device Dossier for Marker, lesion localization, implantable (Marker, lesion localization, implantable, Class IIb, sponsor Emergo). ARTG record, intended…
- GMDN category: Marker, lesion localization, implantable
Intended purpose
This is a single-use sterile device composed of a magnetic marker (seed) preloaded in a Delivery System. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.