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: BrainWatch Headband (SM)/1 pack – 45-51 cm FDA UDI
Model / Reference: 046783 FDA UDI
Description: BrainWatch Headband (SM)/1 pack – 45-51 cm FDA UDI

Identifiers

Primary DI / UDI-DI: 00382830051873 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Analytical scalp electrode, single-use 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

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Analytical scalp electrode, single-use

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

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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

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Manufacturer

Manufacturer: Xltek

Sources (1)

FDA UDI 6088390d-be80-45bf-86ab-2ac5ebfbc183 33 fields · synced Jun 8, 2026