mi-eye 3 T300-075C
mi-eye 3 T300-075C is a Class II device made by Trice Medical, Inc., cleared under FDA 510(k) K212556 on 15 Sep 2021 and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00857356008255), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00857356008255 | Date8 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212556 | Date15 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 00857356008255
- FDA 510(k) database K212556
Across registries
- FDA 510(k) K212556 decided 15 Sep 2021 Active
- FDA GUDID UDI-DI 00857356008255 listed 8 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K212556
- Listed FDA GUDID 00857356008255
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- mi-eye 3
- Generic name
- Rigid optical arthroscope, single-use
- Model / reference
- T300-075C
- Primary DI / UDI-DI
- 00857356008255
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Rigid optical arthroscope, single-use
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
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