FDA-Device2019-12-25Class II
HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
Bio-Signal Group Corp.
Hazard
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Sold states
US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
Affected count
45,375 individual cups Expanded:1314 boxes (24/box)
Manufactured in
3 Post Office Sq Ste K, Acton, MA, United States
Products
HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2020Don't want to check this manually?
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