Cushion 10-397-80
Cushion 10-397-80 is a Class I device made by Reison Medical AB, listed in FDA GUDID since 30 Apr 2022 (UDI-DI 07350111832070), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07350111832070 | Date30 Apr 2022 | StatusListed |
Official records
- AccessGUDID record 07350111832070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Cushion
- Generic name
- Custom-made cushion
- Model / reference
- 10-397-80
- Primary DI / UDI-DI
- 07350111832070
- FDA product code
- FWZ
- GMDN term
- Custom-made cushion
- Device class
- Class I
- Regulation number
- 878.4950
- GUDID distribution status
- In Commercial Distribution
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