Duns Number:547954649
Device Description: Used to detect visual sensitivity, refractive properties and binocular vision of human eye Used to detect visual sensitivity, refractive properties and binocular vision of human eye.
Catalog Number
-
Brand Name
LCD Visual Chart
Version/Model Number
YPB-2100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOX
Product Code Name
Chart, Visual Acuity
Public Device Record Key
3ed93374-5261-4b3b-957b-2d4346eb2ec9
Public Version Date
October 30, 2020
Public Version Number
1
DI Record Publish Date
October 22, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |