FDA-Device2017-11-15Class II
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
Northgate Technologies, Inc.
Hazard
The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.
Sold states
US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Affected count
186
Manufactured in
1591 Scottsdale Ct, N/A, Elgin, IL, United States
Products
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2018Don't want to check this manually?
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