HANDHELD REFRACTOMETER - The NIDEK HANDHELD REFRACTOMETER, HandyRef, - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: The NIDEK HANDHELD REFRACTOMETER, HandyRef, measures spherical, cylindrical refractive err The NIDEK HANDHELD REFRACTOMETER, HandyRef, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye.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.

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More Product Details

Catalog Number

-

Brand Name

HANDHELD REFRACTOMETER

Version/Model Number

HandyRef

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HKO

Product Code Name

Refractometer, Ophthalmic

Device Record Status

Public Device Record Key

3e46968d-f608-4e18-8ea5-295fe38eb41f

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

April 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIDEK CO.,LTD." Characteristics
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