Identity
- Trade Name
- Neurovirtual FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Reusable AgCl cup electrodes 60" length, (5 electrodes/pack) FDA UDI
- Model / Reference
- Maxxi Gold AgCl Electrode 60" Reusable FDA UDI
- Description
- Reusable AgCl cup electrodes 60" length, (5 electrodes/pack) FDA UDI
Identifiers
- Catalog Number
- SI2137 FDA UDI
- Primary DI / UDI-DI
- 00850008393358 FDA UDI
- 510(k) Number
- K163547 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 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
No
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
MR Unsafe FDA UDI
Category: Analytical non-scalp cutaneous electrode
Neurovirtual by Neurovirtual Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Analytical non-scalp cutaneous electrode.
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- SENTIO — Medos International Sàrl · Class II
- Neuroguard — Technomed Engineering B.V. · Class II
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- Alpha — WillowWood Global LLC · Class II
- Alpha — WillowWood Global LLC · Class II
Cleared under the same submission
K163547 also covers:
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, INC.
- Neurovirtual — NEUROVIRTUAL USA, 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
- Neurovirtual Usa, Inc.
Sources (1)
- FDA UDI 4dd9ede5-6e3e-47fc-8119-6cf30556ac10 36 fields · synced Jun 8, 2026