DEVICE: Neuroline CupNeurology Surface Electrode (05707480133697)

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Device Identifier (DI) Information

Neuroline CupNeurology Surface Electrode
72615-M-CM-10
72615-M-CM-10
Ambu A/S
05707480133697
GS1
10
Cup Electrodes - ConMed Colour Kit of 10 pcs (150 cm)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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
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

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Product Code Product Code Name
GXY ELECTRODE, CUTANEOUS
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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
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 60 Inch
Length: 150 Centimeter
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Device Status

In Commercial Distribution
September 22, 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
05707480133673 8 05707480133680 In Commercial Distribution
05707480133680 12 05707480133697 In Commercial Distribution
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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: 05707480133703 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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