MST1009 - Lot F11537107D1 Exp. Date 9-Sept, 2018; MST0815 Lot F11536423D1 Exp. Date 8-Sept, 2018; and, MST1009 Lot F11537109D1 Exp. Date 10-Sept, 2018.
Worldwide Distribution -- USA, including the states of AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.
Description du dispositif
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. || Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
Description du dispositif
Mammotome Revolve Dual Vacuum Assist Biopsy || System || The device is used to sample breast tissue that has been identified as suspicious under imaging guidance