Identity
- Trade Name
- Xavant Technology FDA UDI
- Generic Name
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
- Device Name
- The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response. The STIMPOD (NMS 450) includes Neuromuscular Blocking Agent Monitoring functionality with real-time feedback achieved by tri-axial accelerometry. FDA UDI
- Model / Reference
- STIMPOD NMS450 Kit (3.5m) FDA UDI
- Description
- The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response. The STIMPOD (NMS 450) includes Neuromuscular Blocking Agent Monitoring functionality with real-time feedback achieved by tri-axial accelerometry. FDA UDI
Identifiers
- Catalog Number
- XT-45011A FDA UDI
- Primary DI / UDI-DI
- 06009880396146 FDA UDI
- 510(k) Number
- K102084 FDA UDI
- FDA Product Code
- BXN FDA UDI
- GMDN Term
- Diagnostic peripheral nerve electrical stimulation 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic peripheral nerve electrical stimulation system
Xavant Technology by Xavant Technology (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102084 also covers:
- Xavant Technology — XAVANT TECHNOLOGY (PTY) LTD
- Xavant Technology — XAVANT TECHNOLOGY (PTY) LTD
- Xavant Technology — XAVANT TECHNOLOGY (PTY) LTD
- Xavant Technology — XAVANT TECHNOLOGY (PTY) LTD
- Xavant Technology — XAVANT TECHNOLOGY (PTY) LTD
- Xavant Technology — XAVANT TECHNOLOGY (PTY) LTD
- Xavant Technology — XAVANT TECHNOLOGY (PTY) LTD
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
- Xavant Technology (pty) Ltd
Sources (1)
- FDA UDI 03ba9f6e-91e1-4757-8db0-28d47079ec10 36 fields · synced Jun 1, 2026