FDA.reportPublic FDA data

ATLAS-HS-36-CHET-IDC10

Primary DI
00850011306222
Brand
ATLAS-HS-36-CHET-IDC10
Company
NEURALYNX, INC.
Model
ATLAS-HS-36-CHET-IDC10
Catalog number
31-0601-0087
Device description
The ATLAS-HS-36-CHET-IDC10 is a clinical headstage that allows four X 3M 10 Pin Receptacle Connector (e.g. 8510-4500PL) connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-IDC10 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
Published
2020-04-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011306222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011306222008500113062228500113062220850011306222

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic signal amplifierAn electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4065854542support@neuralynx.com

Regulatory Flags#

DUNS number
933200842
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011306314ATLAS Cart - Dual Monitors31-0605-016931-0605-01692026-04-27
00850011306291High Density Tether 7.5m7.5 meter31-0202-00072026-02-19
00850011306307Tether Extension Cable Male-to-Male 3m3 meter31-0613-00312026-02-19
00850011306338ATLAS Stim Headbox - TouchproofTouchproof31-0601-00892025-06-11
00850011306345ATLAS Stim Headbox - High DensityHigh Density31-0601-01322025-06-11
00850011306703ATLAS Stim Headbox Software1.5.136-0301-00062025-06-11
00850011306710Fiber Optic Connector 2m2m31-0204-00012025-06-11
00850011306727Fiber Optic Connector 7m7m31-0204-00022025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofTouchproof31-0204-00042025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNK31-0204-00032025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityHigh Density31-0204-00052025-06-11
00867718000285ATLAS Stim Headbox - NKNK31-0601-00772025-06-11
00850011306512ATLAS Headbox Expansion PanelATLAS HEP31-0607-00142022-11-10
00850011306970Zipshield 8m8m31-0604-01292024-12-11
00850011306932ATLAS Workstation MonitorATLAS Workstation Monitor31-0000-00022024-12-18
00850011306949ATLAS WorkstationATLAS Workstation31-0004-00002024-12-18
00850011306956ATLAS Parallel TTL CableATLAS Parallel TTL Cable31-0602-00242024-12-18
00850011306239ATLAS Rackmounted Power IsolatorATLAS Rackmounted Power Isolator31-0607-00152024-12-11
00850011306253Ethernet SwitchEthernet Switch31-0604-01392024-12-11
00850011306963Zipshield 5m5m31-0604-01282024-12-11

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