Duns Number:527884077
Device Description: The vision screening instrument is based on the principle of eccentric photo refraction a The vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases.
Catalog Number
-
Brand Name
MediWorks
Version/Model Number
V100
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
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
9b61b1b6-3c05-4633-905d-0724ce9a5f1b
Public Version Date
April 12, 2019
Public Version Number
1
DI Record Publish Date
April 04, 2019
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |