FDA.reportPublic FDA data

AirRay® Electrode Connection Cable US

Primary DI
04260656590157
Brand
AirRay® Electrode Connection Cable US
Company
CorTec GmbH
Model
Extension Cable 32 Channel
Catalog number
4031.1066.02
Published
2022-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
04260656590157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260656590157042606565901574260656590157

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, Specify00Special Storage Condition, Specify: To 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
04260656590164AirRay® Electrode Connection Cable USColor Rings Mini (8 Channel Cable)4031.1039.092022-04-27
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
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
03664539003559NADIXI MEDICALIKD2022-07-06
03664539003566NADIXI MEDICALIKD2022-07-06
03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13