AccessGUDID - DEVICE: CX20N (08809241513056)

GUDID

Device Identifier (DI) Information

Brand Name: CX20N
Version or Model: CX20PUX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WIDE corporation

Primary DI Number: 08809241513056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688285899 *Terms of Use

Device Description: Flat panel hi-resolution LCD monitor system for displaying digital medical images.

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):	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?
36612	Image display unit, colour	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGY	Display, Diagnostic Radiology

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
No Device Sizes

Device Record Status

Public Device Record Key: 5449851e-fb6b-4f6a-80aa-07f4f9d7fec7
Public Version Date: September 30, 2024
Public Version Number: 7
DI Record Publish Date: September 21, 2016