Duns Number:557804864
Device Description: Medizs LED Visual Acuity Chart LC-13 is various chart for helping patient to make a vision Medizs LED Visual Acuity Chart LC-13 is various chart for helping patient to make a vision test.It has Snellen, Landolt, etc.
Catalog Number
LC-13
Brand Name
Medizs LED VIsual Acuity Chart LC-13
Version/Model Number
LC-13
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"
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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
2d3390b2-ffae-469e-87ca-7d9c9c6417d2
Public Version Date
March 31, 2021
Public Version Number
1
DI Record Publish Date
March 23, 2021
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 | 4 |