AccessGUDID - DEVICE: Chalgren (00816020020887)

GUDID

Device Identifier (DI) Information

Brand Name: Chalgren
Version or Model: 445-10G-60TP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 445-10G-60TP
Company Name: CHALGREN ENTERPRISES

Primary DI Number: 00816020020887
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085932630 *Terms of Use

Device Description: Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 60 inch PVC Leadwire (Assorted Colors)

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:	No
Prescription Use (Rx):	No
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
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Inch

Device Record Status

Public Device Record Key: c49c67d0-52f5-41db-8cb4-71db4bcfb094
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2016