Profile: Ursus Medical AB manufactures and markets medical instruments & equipment for the diagnosis & treatment of cancer. The Rotex screw needle biopsy instrument consists of a thin screw needle housed in a cannula with an outer diameter of 0.8 or 1 mm and a special instrument holder. Since material is excised instead of being aspirated, complete cell clusters are obtained rather than single cells. As a result, at least 95% diagnostic accuracy has been obtained using Rotex for sampling lung tumours and non-palpable breast tumours. The diameter of the instrument cannula is 0.8 or 1.0 mm, which explains the low incidence of reported complications.
FDA Registration Number: 8030863
US Agent: Patrickj.hatch / Hatch Medical Products, Inc.
Phone: +1-(414)-383- Fax: +1-(414)-383- E-Mail:
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| • General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |