Natus

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name: Natus FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: Reusable Molded Silver EEG 10mm Disc Electrodes with 48" (1.2m) PVC lead wires FDA UDI
Model / Reference: Silver Disc Electrode FDA UDI
Description: Reusable Molded Silver EEG 10mm Disc Electrodes with 48" (1.2m) PVC lead wires FDA UDI

Identifiers

Catalog Number: 101091 FDA UDI
Primary DI / UDI-DI: 00382830001489 FDA UDI
FDA Product Code: EWO FDA UDI
GWJ FDA UDI
GMDN Term: Evoked-potential audiometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1050 FDA UDI
882.1900 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

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

Dimensions & Sizes

Size: Length — 1.2 Meter FDA UDI

Category: Evoked-potential audiometer

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

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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 Medical Incorporated

Sources (1)

FDA UDI db470ebc-9cc3-4795-bffa-71360b481f9d 36 fields · synced May 31, 2026