Identity
- Trade Name
- NIM-Neuro® FDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- MAINFRAME 8253401 NIM NEURO 3.0 EL ROHS FDA UDI
- Model / Reference
- 8253401 FDA UDI
- Description
- MAINFRAME 8253401 NIM NEURO 3.0 EL ROHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169547070 FDA UDI
- 510(k) Number
- K083124 FDA UDI
- FDA Product Code
- GWF FDA UDIETN FDA UDI
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI874.1820 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: Nerve-locating system
NIM-Neuro® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve-locating system.
- Guardian Probe Extension, 4 cm — Checkpoint Surgical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- SENTIO — Medos International Sàrl · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
Cleared under the same submission
K083124 also covers:
- APS™ — MEDTRONIC XOMED, INC.
- APS™ — MEDTRONIC XOMED, INC.
- APS™ — MEDTRONIC XOMED, INC.
- NIM — MEDTRONIC XOMED, INC.
- NIM Neuro — MEDTRONIC XOMED, INC.
- NIM Neuro — MEDTRONIC XOMED, INC.
- NIM-Neuro® — MEDTRONIC XOMED, INC.
- NIM-Neuro® — MEDTRONIC XOMED, INC.
- NIM-Neuro® — MEDTRONIC XOMED, INC.
- NIM-Neuro® — MEDTRONIC XOMED, INC.
- NIM-Neuro® — MEDTRONIC XOMED, INC.
- NIM-Neuro® — 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 Xomed, Inc.
Sources (1)
- FDA UDI c4a4a21a-4a26-469c-8408-d5c78614effd 36 fields · synced May 31, 2026