DEVICE: Bio-logic (00382830008365)

Device Identifier (DI) Information

Bio-logic
Disposable Snap Electrodes
In Commercial Distribution
101600; 101603
NATUS MEDICAL INCORPORATED
00382830008365
GS1

1
962519208 *Terms of Use
Disposable Snap Electrodes
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Analytical scalp electrode, single-use A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
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FDA Product Code

[?]
Product Code Product Code Name
EWO Audiometer
GWJ Stimulator, Auditory, Evoked Response
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031009 000
K073626 000
K083371 000
K112247 000
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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
Length: 1.31 Inch
Width: 0.88 Inch
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Device Record Status

46e9cc32-c0a5-4552-a52c-6037ca92a259
July 06, 2018
3
December 30, 2016
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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
00382830001427 300 00382830008365 2017-08-01 Not in Commercial Distribution 101603
00382830001410 60 00382830008365 2017-08-01 Not in Commercial Distribution 101600
00382830054928 100 00382830008365 In Commercial Distribution 101603
00382830054911 20 00382830008365 In Commercial Distribution 101600
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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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-303-0306
BLSC_Hearing_Support@natus.com
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