Device Dossier
Gel Mark Ultra Biopsy Site Marker - Marker, lesion localization, implantable
Device Dossier for Gel Mark Ultra Biopsy Site Marker - Marker, lesion localization, implantable (Marker, lesion localization, implantable, Class III,…
- GMDN category: Marker, lesion localization, implantable
Intended purpose
An implant used to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
Functional description
A disposable applicator containing resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets with an embedded stainless steel radiopaque wireform, intended for long term radiographic marking of the biospy site. Pellets are visible via ultrasound for approx. 6 weeks and resorbed in approx. 12 weeks. The pellets are deployed from the applicator through the biopsy device into the biopsy cavity.