Atlas-Hs-36-Chet-D18

FDA UDI

Class II (US FDA UDI)

by Neuralynx, Inc.

Identity

Trade Name: ATLAS-HS-36-CHET-D18 FDA UDI
Generic Name: Electroencephalographic signal amplifier FDA UDI
Device Name: The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-D18 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized. FDA UDI
Model / Reference: ATLAS-HS-36-CHET-D18 FDA UDI
Description: The ATLAS-HS-36-CHET-D18 is a clinical headstage that allows two 18 contact DIXI electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-D18 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized. FDA UDI

Identifiers

Catalog Number: 31-0601-0082 FDA UDI
Primary DI / UDI-DI: 00867718000292 FDA UDI
FDA Product Code: GWL FDA UDI
GMDN Term: Electroencephalographic signal amplifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1835 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electroencephalographic signal amplifier

Atlas-Hs-36-Chet-D18 by Neuralynx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalographic signal amplifier.

XactTrode Patient Cable — Blackrock Microsystems · Class II
eego amplifier — eemagine Medical Imaging Solutions GmbH · Class II
XactTrode Patient Cable — Blackrock Microsystems · Class II
XactTrode Patient Cable — Blackrock Microsystems · Class II
XactTrode Patient Cable — Blackrock Microsystems · Class II
Component Neuromonitoring System — Moberg Research, Inc. · Class II
NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
XactTrode Patient Cable — Blackrock Microsystems · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Neuralynx, Inc.

Sources (1)

FDA UDI 2f950c21-ce05-4c39-a3da-5f3008d6b317 35 fields · synced May 30, 2026