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: Nicolet Reflex Hammer Assembly FDA UDI
Model / Reference: 222-408600 FDA UDI
Description: Nicolet Reflex Hammer Assembly FDA UDI

Identifiers

Primary DI / UDI-DI: 00382830038478 FDA UDI
510(k) Number: K112052 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

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

K112052 also covers:

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 fd8ec4d1-74cf-4bad-8b0c-835ee20b24c0 34 fields · synced Jun 9, 2026