Device Dossier
Marker, lesion localization, implantable
Device Dossier for Marker, lesion localization, implantable (Marker, lesion localization, implantable, Class IIb, sponsor Hologic (Australia & New…
- GMDN category: Marker, lesion localization, implantable
Intended purpose
Intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. The devices are indicated for use to radiographically and radiologically mark the location in breasts tissue following an open or percutaneous procedure. They are not intended to be used with magnetic resonance imaging (MRI) techniques.