DEVICE: ATLAS Headbox Expansion Panel (00850011306512)
Device Identifier (DI) Information
ATLAS Headbox Expansion Panel
ATLAS HEP
In Commercial Distribution
31-0607-0014
NEURALYNX, INC.
ATLAS HEP
In Commercial Distribution
31-0607-0014
NEURALYNX, INC.
The ATLAS Headbox Expansion Panel is an accessory to the ATLAS Neurophysiology System and ATLAS Stim Headbox. The HEP is a power module and a signal splitter.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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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 |
35726 | Somatosensory electrical stimulation system |
An assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GYC | Electrode, Cortical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K110967 | 000 |
K250094 | 000 |
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
747bbe12-8672-4023-bbf7-447fcf8f3e2f
June 10, 2025
3
November 10, 2022
June 10, 2025
3
November 10, 2022
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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
406-585-4542
support@neuralynx.com
support@neuralynx.com