DEVICE: NATUS NEUROLOGY (00382830037006)

Device Identifier (DI) Information

NATUS NEUROLOGY
515-021500
In Commercial Distribution

NATUS NEUROLOGY INCORPORATED
00382830037006
GS1

1
874257488 *Terms of Use
10-20 Headbox kit for Wireless EEG Amplifier
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electroencephalographic signal amplifier An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them. It could typically be used when using an electroencephalograph (EEG).
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FDA Product Code

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Product Code Product Code Name
GWL Amplifier, Physiological Signal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103140 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5361ab0a-9056-4978-b7ef-13962c0339cb
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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