Duns Number:690635461
Device Description: The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical refractive The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye.The keratometer measures the corneal curvature radius (corneal refractive power) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power.This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room.
Catalog Number
-
Brand Name
HANDHELD REF / KERATOMETER
Version/Model Number
HandyRef-K
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
b9ba98ea-703d-4b07-91bc-aaa0790e8e9b
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
April 20, 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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |