DEVICE: ATLAS-HS-36-CHET-A9 (00850011306215)
Device Identifier (DI) Information
ATLAS-HS-36-CHET-A9
ATLAS-HS-36-CHET-A9
In Commercial Distribution
31-0601-0086
NEURALYNX, INC.
ATLAS-HS-36-CHET-A9
In Commercial Distribution
31-0601-0086
NEURALYNX, INC.
The ATLAS-HS-36-CHET-A9 is a clinical headstage that allows four X 9 contact Adtech electrode connectors to interface with the ATLAS Data Acquisition System. The ATLAS-HS-36-CHET-A9 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36740 | Electroencephalographic signal amplifier |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GWL | Amplifier, Physiological Signal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
295ec203-dba3-4bf9-914f-816442bc5a89
July 13, 2023
3
April 07, 2020
July 13, 2023
3
April 07, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
4065854542
support@neuralynx.com
support@neuralynx.com