DEVICE: Bio-logic (00382830008365)
Device Identifier (DI) Information
Bio-logic
Disposable Snap Electrodes
In Commercial Distribution
101600; 101603
NATUS MEDICAL INCORPORATED
Disposable Snap Electrodes
In Commercial Distribution
101600; 101603
NATUS MEDICAL INCORPORATED
Disposable Snap Electrodes
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EWO | Audiometer |
GWJ | Stimulator, Auditory, Evoked Response |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K031009 | 000 |
K073626 | 000 |
K083371 | 000 |
K112247 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 1.31 Inch |
Width: 0.88 Inch |
Device Record Status
46e9cc32-c0a5-4552-a52c-6037ca92a259
July 06, 2018
3
December 30, 2016
July 06, 2018
3
December 30, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
1-800-303-0306
BLSC_Hearing_Support@natus.com
BLSC_Hearing_Support@natus.com