Identity
- Trade Name
- AVANOS FDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- EZstim* Peripheral Nerve Stimulator/Nerve Locator FDA UDI
- Model / Reference
- 44735 FDA UDI
- Description
- EZstim* Peripheral Nerve Stimulator/Nerve Locator FDA UDI
Identifiers
- Catalog Number
- MB500 FDA UDI
- Primary DI / UDI-DI
- 00193494447359 FDA UDI
- 510(k) Number
- K162048 FDA UDI
- FDA Product Code
- KOI FDA UDI
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2775 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nerve-locating system
Avanos by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve-locating system.
- NIM Vital — MEDTRONIC XOMED, INC. · Class II
- Guardian Probe Extension, 4 cm — Checkpoint Surgical, Inc. · Class II
- NIM-ECLIPSE® — MEDTRONIC XOMED, INC. · Class II
- NIM-Eclipse® — MEDTRONIC XOMED, INC. · Class II
- SENTIO — Medos International Sàrl · Class II
- NIM-Response® — MEDTRONIC XOMED, INC. · Class II
- NIM-Neuro® — MEDTRONIC XOMED, INC. · Class II
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Cleared under the same submission
K162048 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 4925301b-c3f2-44a5-9a0c-5711e02d956a 36 fields · synced Jun 9, 2026