Natus

FDA UDI

Class II (US FDA UDI)

by Xltek

Identity

Trade Name: Natus FDA UDI
Generic Name: Analytical scalp electrode, single-use FDA UDI
Device Name: Neonatal Sensors FDA UDI
Model / Reference: CZA00037 FDA UDI
Description: Neonatal Sensors FDA UDI

Identifiers

Primary DI / UDI-DI: 00382830058506 FDA UDI
FDA Product Code: OMB FDA UDI
GMDN Term: Analytical scalp electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Analytical scalp electrode, single-use

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

Similar devices

Also classified as Analytical scalp electrode, single-use.

Cadwell Single Disc Electrode — Cadwell Industries, Inc. · Class II
Rhythmlink® — Rhythmlink International, LLC · Class II
Rhythmlink® — Rhythmlink International, LLC · Class II
Cadwell EEG Gold Cup Electrode — Cadwell Industries, Inc. · Class II
Rhythmlink® — Rhythmlink International, LLC · Class II
Neuroline Cup — Ambu A/S · Class II
Zeto ONE Short-Term Electrode Set — ZETO INC · Class II
BRAINSTREAM — Conmed Corporation · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Xltek

Sources (1)

FDA UDI 93904fdd-05f6-47e1-8164-a2cc4fbd4e85 33 fields · synced Jun 8, 2026