Skip to contentDe Novo DEN210004
- Device
- Zuno Smart Sterilization Container
- Contact
- allan mcnichol
- De Novo number
- DEN210004
- Product code
- QJT
- Regulation
- 880.6855
- Classification name
- rigid sterilization container with software
- Decision
- granted (DENG)
- Decision date
- 2022-06-17
- Date received
- 2021-02-16
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QJT
- Device name
- Rigid Sterilization Container With Software
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.6855
- Implant
- N
- Life sustain/support
- N