Midas Rex™ EA100
by Medtronic Powered Surgical Solutions 2 variants
Midas Rex™ EA100 is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K012453 on 22 Oct 2001 and listed in FDA GUDID since 3 Mar 2018 (UDI-DI 00721902573583), 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 | Number00721902573583 | Date3 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012453 | Date22 Oct 2001 | StatusActive |
Official records
- AccessGUDID record 00721902573583
- FDA 510(k) database K012453
Across registries
- FDA 510(k) K012453 decided 22 Oct 2001 Active
- FDA GUDID UDI-DI 00721902573583 listed 3 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K012453
- Listed FDA GUDID 00721902573583
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Midas Rex™
- Generic name
- Instrument tray, reusable
- Model / reference
- EA100
- Primary DI / UDI-DI
- 00721902573583
- 510(k) Number
- FDA product code
- HBE
- GMDN term
- Instrument tray, reusable
- Device class
- Class II
- Regulation number
- 882.4310
- GUDID distribution status
- In Commercial Distribution
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