AUTO REF/KERATO/TONOMETER - AUTO REF/KERATO/TONOMETER Model TONOREF II is - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refract AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

AUTO REF/KERATO/TONOMETER

Version/Model Number

TONOREF II

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

e208f396-dfbe-414e-9c05-6d6dcbc9a922

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

June 24, 2016

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