AccessGUDID - DEVICE: Steris (05415334051119)

GUDID

Device Identifier (DI) Information

Brand Name: Steris
Version or Model: VividImage 32 4K without decoder
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RLM324KBSND
Company Name: Barco NV

Primary DI Number: 05415334051119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 371618773 *Terms of Use

Device Description: VividImage 32 4K without decoder

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
KQM	Camera, Surgical And Accessories

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: 0ca0f3ad-1a76-407f-82f4-25e79e21ce1f
Public Version Date: February 19, 2025
Public Version Number: 1
DI Record Publish Date: February 11, 2025