AccessGUDID - DEVICE: Clinical review 2MP (05415334000445)

GUDID

Device Identifier (DI) Information

Brand Name: Clinical review 2MP
Version or Model: MDRC-2224
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K9301807A
Company Name: Barco NV

Primary DI Number: 05415334000445
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 371618773 *Terms of Use

Device Description: MDRC-2224 WH MKII

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
LMD	System, digital image communications, radiological

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: 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: 6980e4ee-4571-40a1-a3b1-8bcde36171b7
Public Version Date: May 03, 2024
Public Version Number: 5
DI Record Publish Date: June 30, 2016