AccessGUDID - DEVICE: Neuroline CupNeurology Surface Electrodes (05707480021628)

GUDID

Device Identifier (DI) Information

Brand Name: Neuroline CupNeurology Surface Electrodes
Version or Model: 72610-M/10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72610-M/10
Company Name: Ambu A/S

Primary DI Number: 05707480021628
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Cup Electrodes M Connector Lead Wire Length: 100 cm (40")

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":	Yes
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?
11440	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	ELECTRODE, CUTANEOUS

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 40 Inch
Length: 100 Centimeter

Device Record Status

Public Device Record Key: 09fb29e8-93b8-4c4c-a58e-5443e7409110
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016