Nim-Eclipse® 945NCCPUE4
by Medtronic Sofamor Danek, Inc.
Nim-Eclipse® 945NCCPUE4 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K061639 on 1 Nov 2006 and listed in FDA GUDID since 30 Jul 2018 (UDI-DI 00763000102388), active as of 23 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 | Number00763000102388 | Date30 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061639 | Date1 Nov 2006 | StatusActive |
Official records
- AccessGUDID record 00763000102388
- FDA 510(k) database K061639
Across registries
- FDA 510(k) K061639 decided 1 Nov 2006 Active
- FDA GUDID UDI-DI 00763000102388 listed 30 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K061639
- Listed FDA GUDID 00763000102388
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nim-Eclipse®
- Generic name
- Portable computer
- Model / reference
- 945NCCPUE4
- Primary DI / UDI-DI
- 00763000102388
- 510(k) Number
- FDA product code
- GWF, IYN
- GMDN term
- Portable computer
- Device class
- Class II
- Regulation number
- 882.1870, 892.1550
- GUDID distribution status
- In Commercial Distribution
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