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

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

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Disponible desde:

Bard Australia Pty Ltd

clase:

Class III

Fabricado por:

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

Área terapéutica:

40808 - Marker, lesion localization, implantable

indicaciones terapéuticas:

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.

Estado de Autorización:

A

Fecha de autorización:

2009-03-11

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