Identity
- Trade Name
- NIM-ECLIPSE® FDA UDI
- Generic Name
- Portable computer FDA UDI
- Device Name
- COMPUTER 945NCCPUE4 LAPTOP FDA UDI
- Model / Reference
- 945NCCPUE4 FDA UDI
- Description
- COMPUTER 945NCCPUE4 LAPTOP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000102388 FDA UDI
- 510(k) Number
- K061639 FDA UDI
- FDA Product Code
- GWF FDA UDIIYN FDA UDI
- GMDN Term
- Portable computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI892.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Portable computer
Nim-Eclipse® by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K061639 also covers:
- NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse® — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse® — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse® — MEDTRONIC SOFAMOR DANEK, INC.
- NIM Eclipse — MEDTRONIC XOMED, INC.
- NIM Eclipse — MEDTRONIC XOMED, INC.
- NIM Eclipse — MEDTRONIC XOMED, INC.
- NIM-ECLIPSE — MEDTRONIC XOMED, INC.
- NIM-ECLIPSE® — MEDTRONIC XOMED, INC.
- NIM-ECLIPSE® — MEDTRONIC XOMED, INC.
- NIM-ECLIPSE® — MEDTRONIC XOMED, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI ff278e6c-bc5f-435f-8717-6014f97b3a17 36 fields · synced Jun 8, 2026