FDA-Device2017-03-29Class II
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Devicor Medical Products Inc
Hazard
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Sold states
Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
Affected count
320
Manufactured in
300 E Business Way Fl 5, Cincinnati, OH, United States
Products
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2017Don't want to check this manually?
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