AccessGUDID - DEVICE: AirRay® Electrode Connection Cable US (04260656590003)

GUDID

Device Identifier (DI) Information

Brand Name: AirRay® Electrode Connection Cable US
Version or Model: Connector Block 8 Channel
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4011.1021.02
Company Name: CorTec GmbH

Primary DI Number: 04260656590003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341740910 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35749	Analytical scalp lead	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	Cable, Electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special 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.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c4f21d1-275a-49e0-815a-d3c586fdea71
Public Version Date: May 05, 2022
Public Version Number: 1
DI Record Publish Date: April 27, 2022