Duns Number:078605507
Device Description: The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is designed to provide a comprehensive system for measuring visual acuity.
Catalog Number
-
Brand Name
IBEX LCD digital acuity chart
Version/Model Number
AC
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
623da2f6-f2ad-49d8-81da-8e51cfb5c459
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 01, 2018
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |