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.
00850011306215
GS1

1
933200842 *Terms of Use
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.
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GWL Amplifier, Physiological Signal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

295ec203-dba3-4bf9-914f-816442bc5a89
July 13, 2023
3
April 07, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
4065854542
support@neuralynx.com
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