Duns Number:557804864
Device Description: Medizs Digitalized Refractor DR-19 is an automated digital phoropter.Operator can use it t Medizs Digitalized Refractor DR-19 is an automated digital phoropter.Operator can use it to find right eye glasses for patient's vision correction.
Catalog Number
DR-19
Brand Name
Medizs Digitalized Refractor DR-19
Version/Model Number
DR-19
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
HKN
Product Code Name
Refractor, Manual, Non-Powered, Including Phoropter
Public Device Record Key
2efbe731-0ddd-4d33-9c9c-b0cc4fd5f7e1
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 |