Natus

FDA UDI

Class II (US FDA UDI)

by Natus Neurology Incorporated

Identity

Trade Name: Natus FDA UDI
Generic Name: Analytical non-scalp cutaneous electrode FDA UDI
Device Name: Disposable Pre-Gelled Surface Electrode, 20mm X 25mm, 2.0m (79") lead, (1.5mm DIN), 12/pouch FDA UDI
Model / Reference: 454040 FDA UDI
Description: Disposable Pre-Gelled Surface Electrode, 20mm X 25mm, 2.0m (79") lead, (1.5mm DIN), 12/pouch FDA UDI

Identifiers

Primary DI / UDI-DI: 00382830041492 FDA UDI
510(k) Number: K850108 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Analytical non-scalp cutaneous electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Analytical non-scalp cutaneous electrode

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 6b4a8246-b905-4b58-90ba-3d907cbd573f 34 fields · synced Jun 9, 2026