Natus

FDA UDI

Class II (US FDA UDI)

by Natus Neurology Incorporated

Identity

Trade Name: Natus FDA UDI
Generic Name: Electromyograph FDA UDI
Device Name: EMG Surface Temperature Probe FDA UDI
Model / Reference: 268-411800 FDA UDI
Description: EMG Surface Temperature Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 00382830038188 FDA UDI
510(k) Number: K890495 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electromyograph

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

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Cleared under the same submission

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: Natus Neurology Incorporated

Sources (1)

FDA UDI ec5f6c10-2eeb-4aa6-81ad-c81e9c940028 34 fields · synced Jun 9, 2026