AccessGUDID - DEVICE: Evolution4K (00817613020857)

GUDID

Device Identifier (DI) Information

Brand Name: Evolution4K
Version or Model: Evo4K130
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Nds Surgical Imaging LLC

Primary DI Number: 00817613020857
Issuing Agency: GS1
Commercial Distribution End Date: September 04, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 081712583 *Terms of Use

Device Description: LCD touch screen recording system with HDMI loop through. Software version update 1.7.14

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?
18034	Endoscopic video image processing unit	An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMB	Device, Digital Image Storage, 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
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: more than 94 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 105 KiloPascal
Handling Environment Humidity: more than 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 16 and 26 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c2ecfb5-0347-4c2a-809d-bd406d44230b
Public Version Date: November 27, 2024
Public Version Number: 7
DI Record Publish Date: March 04, 2020