Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Coopersurgical recently completed validation of a new disinfection procedure and the wallach ll100 cryosurgery system directions for use (dfu) has been updated. furthermore coopersurgical has determined that the useful life of the affected product is 5 years based on a 650 maximum reprocessing cycles.
Model Catalog: 900020 (Lot serial: All lots); Model Catalog: 900001 (Lot serial: All lots); Model Catalog: 900002 (Lot serial: All lots); Model Catalog: 900150 (Lot serial: All lots); Model Catalog: 900162 (Lot serial: All lots); Model Catalog: 900629 (Lot serial: All lots); Model Catalog: 900502-4 (Lot serial: All lots); Model Catalog: 900630 (Lot serial: All lots); Model Catalog: 900506-2-N2O (Lot serial: All lots); Model Catalog: 900506-1-N2O (Lot serial: All lots); Model Catalog: 900001A-NO2 (Lot serial: All lots); Model Catalog: 900506-2-CO2 (Lot serial: All lots)
제품 설명
WALLACH LL100 TWO-TRIGGER CRYOSURGICAL UNIT FOR N2O