De Novo DEN220041
- Device
- Tristel Duo ULT
- Contact
- julija shabanova
- De Novo number
- DEN220041
- Product code
- QWS
- Regulation
- 880.6886
- Classification name
- foam or gel chemical sterilant/high level disinfectant
- Decision
- granted (DENG)
- Decision date
- 2023-06-02
- Date received
- 2022-06-29
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QWS
- Device name
- Foam Or Gel Chemical Sterilant/High Level Disinfectant
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6886
- Implant
- N
- Life sustain/support
- N