Gel Mark Ultra Biopsy Site Marker - Marker, lesion localization, implantable

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Dostupné z:

Bard Australia Pty Ltd

Trieda:

Class III

Výrobca:

SenoRx Inc 1625 W 3rd Street, Tempe, AZ, 82581 United States Of America

Terapeutické oblasti:

40808 - Marker, lesion localization, implantable

Terapeutické indikácie:

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. An implant used to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Stav Autorizácia:

A

Dátum Autorizácia:

2009-03-11