AccessGUDID - DEVICE: Vision-C 600 (03615020000670)

GUDID

Device Identifier (DI) Information

Brand Name: Vision-C 600
Version or Model: VRS001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ESSILOR INTERNATIONAL

Primary DI Number: 03615020000670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 277373213 *Terms of Use

Device Description: Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.

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?
36380	Visual acuity light box	A mains electricity (AC-powered) light viewing box that uses a translucent version of the ophthalmic chart (Snellen chart) imprinted with block letters (optotypes) and/or other symbols (e.g., LEA symbols for children who can not read) in gradually decreasing sizes used for testing visual acuity. The letters/symbols are identified according to distances at which they are ordinarily visible (normally 6 metres or 20 feet) and are combined in a box where the individual letters or symbols are selected and high-lighted by the optician/doctor with background electrical lighting. This device is typically mounted on a wall of the optician/doctor's examination room/office.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOX	Chart, Visual Acuity

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 Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 716bddf7-d3b6-42d9-8fd5-6048eee1363e
Public Version Date: October 06, 2023
Public Version Number: 1
DI Record Publish Date: September 28, 2023