Identity
- Trade Name
- Xavant Technology FDA UDI
- Generic Name
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
- Device Name
- This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) connector is designed to clip on to a standard ECG electrode. The 2mm needle connector will accommodate various makes of needles. FDA UDI
- Model / Reference
- Nerve Locate Cable FDA UDI
- Description
- This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) connector is designed to clip on to a standard ECG electrode. The 2mm needle connector will accommodate various makes of needles. FDA UDI
Identifiers
- Catalog Number
- XT-41003 FDA UDI
- Primary DI / UDI-DI
- 06009880396085 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 2b6e8882-a32b-43ae-96fc-17e8bbf27ca2 36 fields · synced May 30, 2026