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Bio-logic

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name
Bio-logic FDA UDI
Generic Name
Analytical scalp electrode, single-use FDA UDI
Device Name
Halo Ear Muffins with Tab Electrodes FDA UDI
Model / Reference
Halo Ear Muffin with Tab Electrode FDA UDI
Description
Halo Ear Muffins with Tab Electrodes FDA UDI

Identifiers

Catalog Number
206202 FDA UDI
Primary DI / UDI-DI
00382830000987 FDA UDI
FDA Product Code
EWO FDA UDI
GWJ FDA UDI
GMDN Term
Analytical scalp electrode, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Analytical scalp electrode, single-useAcoustic earmuffs

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

Similar devices

Also classified as Acoustic earmuffs.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Incorporated

Sources (1)

  • FDA UDI d29cd0c8-ef95-4cd1-ad29-f3359e6abbdb 36 fields · synced Jun 1, 2026