Device product
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Z-0234-2023
Product summary
- Firm
- Sonendo Inc
- Event
- Event 91045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 instruments
- Official record key
device-enforcement:Z-0234-2023
Official wording
Reason: Procedure Instruments with erroneous unit carton labels.
Code information: GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R
Distribution pattern: Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Derived failure modes
-
Unknown
Procedure Instruments with erroneous unit carton labels.