FDA.reportPublic FDA data

AirRay® Electrode Connection Cable US

Primary DI
04260656590164
Brand
AirRay® Electrode Connection Cable US
Company
CorTec GmbH
Model
Color Rings Mini (8 Channel Cable)
Catalog number
4031.1039.09
Published
2022-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260656590164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260656590164042606565901644260656590164

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp leadA wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature (20°C±15°C/68°F±27°F) and non-condensing humidity conditions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4976170888100support@cortec-neuro.com

Regulatory Flags#

DUNS number
341740910
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260656590003AirRay® Electrode Connection Cable USConnector Block 8 Channel4011.1021.022022-04-27
04260656590034AirRay® Electrode Connection Cable USConnector Block 32 Channel4011.1024.022022-04-27
04260656590041AirRay® Electrode Connection Cable USPatient Cable 8 Channel4031.1055.022022-04-27
04260656590072AirRay® Electrode Connection Cable USPatient Cable 32 Channel4031.1058.022022-04-27
04260656590089AirRay® Electrode Connection Cable USMED Cable 8 Channel4031.1059.022022-04-27
04260656590119AirRay® Electrode Connection Cable USMED Cable 32 Channel4031.1062.022022-04-27
04260656590126AirRay® Electrode Connection Cable USExtension Cable 8 Channel4031.1063.022022-04-27
04260656590157AirRay® Electrode Connection Cable USExtension Cable 32 Channel4031.1066.022022-04-27
04260656590171AirRay® Electrode Connection Cable USColor Rings Maxi (16/ 24/ 32 Channel Cable)4031.1038.092022-04-27
04260656590188AirRay® Electrode Connection Cable USPatient Cable Set 8 Channel4031.1018.022022-04-27
04260656590195AirRay® Electrode Connection Cable USPatient Cable Set 32 Channel4031.1019.022022-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50885380213258KendallCardinal Health 200, LLCIKD2026-10-28
06946725572931APKAPK Technology Co.,Ltd.IKD2026-10-26
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
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