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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Bard Australia Pty Ltd

Class:

Class III

Manufactured by:

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

Therapeutic area:

40808 - Marker, lesion localization, implantable

Therapeutic indications:

A disposable applicator containing resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets with an embedded titanium 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.

Authorization status:

A

Authorization date:

2009-03-11