FDA-Device2022-07-27Class III
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Stryker Instruments Div. of Stryker Corporation
Hazard
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
Sold states
US Nationwide.
Affected count
51 units
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1394-2022Don't want to check this manually?
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