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X-Series

FDA UDI

Class II (US FDA UDI)

by Advanced Brain Monitoring, Inc.

Identity

Trade Name
X-Series FDA UDI
Generic Name
Analytical scalp electrode, single-use FDA UDI
Device Name
X24 Disposable Sensor Kit FDA UDI
Model / Reference
XS24-4321 FDA UDI
Description
X24 Disposable Sensor Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00851113007512 FDA UDI
510(k) Number
K131383 FDA UDI
FDA Product Code
OMC FDA UDI
GWQ FDA UDI
GMDN Term
Analytical scalp electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

X-Series by Advanced Brain Monitoring, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K131383 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Brain Monitoring, Inc.

Sources (1)

  • FDA UDI 37d6dfb2-9ab2-4b00-b890-99fd68579400 35 fields · synced Jun 8, 2026