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Xavant Technology

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref XT-45021Model STIMPOD NMS450

by Xavant Technology (pty) Ltd

Identity

Trade Name
STIMPOD Quantitative NMT Monitor EUDAMED
Xavant Technology FDA UDI
Generic Name
Diagnostic peripheral nerve electrical stimulation system FDA UDI
Device Name
STIMPOD NMS450 Quantitative NMT Monitor EUDAMED
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 EUDAMED
XT-45021 EUDAMED
STIMPOD NMS450 Kit 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-45021 FDA UDI
Primary DI / UDI-DI
06009880396313 EUDAMEDFDA UDI
Basic UDI-DI
B-06009880396313 EUDAMED
510(k) Number
K102084 FDA UDI
FDA Product Code
BXN FDA UDI
EMDN Code
Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER EUDAMED
GMDN Term
Diagnostic peripheral nerve electrical stimulation system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
868.2775 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic peripheral nerve electrical stimulation system.

Cleared under the same submission

K102084 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xavant Technology (pty) Ltd

Sources (2)

  • FDA UDI 33ee9b4e-6fd0-4f08-9f3f-45226d4594fe 36 fields · synced Jul 29, 2026
  • EUDAMED f254aaf2-3977-4a9e-83a1-7906a00028bc 61 fields · synced Jul 29, 2026