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Natus

FDA UDI

Class II (US FDA UDI)

by Xltek

Identity

Trade Name
Natus FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
Xltek NeuroMax CE 1004 Main Unit - White FDA UDI
Model / Reference
10438 FDA UDI
Description
Xltek NeuroMax CE 1004 Main Unit - White FDA UDI

Identifiers

Primary DI / UDI-DI
00382830000567 FDA UDI
510(k) Number
K941144 FDA UDI
FDA Product Code
IKN FDA UDI
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Category: Electromyograph

Natus by Xltek — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromyograph.

Cleared under the same submission

K941144 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xltek

Sources (1)

  • FDA UDI 560e3354-b46d-4161-81f2-013aeff657f5 34 fields · synced May 30, 2026