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Natus Neurology

FDA UDI

Class II (US FDA UDI)

by Natus Neurology Incorporated

Identity

Trade Name
NATUS NEUROLOGY FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
PATIENT INTERFACE UNIT-FIXED FDA UDI
Model / Reference
S035K020F FDA UDI
Description
PATIENT INTERFACE UNIT-FIXED FDA UDI

Identifiers

Primary DI / UDI-DI
00382830028998 FDA UDI
510(k) Number
K965065 FDA UDI
FDA Product Code
GWF FDA UDI
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1870 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electromyograph

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

Similar devices

Also classified as Electromyograph.

Cleared under the same submission

K965065 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Neurology Incorporated

Sources (1)

  • FDA UDI aaba499f-7d07-486d-bd7f-61f7338ad143 34 fields · synced Jun 9, 2026