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Xavant Technology

FDA UDI

Class II (US FDA UDI)

by Xavant Technology (pty) Ltd

Identity

Trade Name
Xavant Technology FDA UDI
Generic Name
Diagnostic peripheral nerve electrical stimulation system FDA UDI
Device Name
The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to the nerve mapping probe. The distance of the nerve mapping probe from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response. FDA UDI
Model / Reference
STIMPOD NMS415 KIT FDA UDI
Description
The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to the nerve mapping probe. The distance of the nerve mapping probe from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response. FDA UDI

Identifiers

Catalog Number
XT-41501 FDA UDI
Primary DI / UDI-DI
06009880396023 FDA UDI
510(k) Number
K093591 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

Similar devices

Also classified as Diagnostic peripheral nerve electrical stimulation system.

Cleared under the same submission

K093591 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xavant Technology (pty) Ltd

Sources (1)

  • FDA UDI 0ce80037-db0c-4bd6-b716-c603111784a4 36 fields · synced May 30, 2026