AUTO REF/KERATOMETER

GUDID 04987669100738

The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power.

NIDEK CO.,LTD.

Bench-top keratometer
Primary Device ID04987669100738
NIH Device Record Key830086bc-8c03-4d1e-841a-99e48a703c2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTO REF/KERATOMETER
Version Model NumberARK-1s
Company DUNS690635461
Company NameNIDEK CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com
Phone1-800-223-9044
Emailinfo@nidek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104987669100738 [Primary]

FDA Product Code

HLQKeratoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-08-10

On-Brand Devices [AUTO REF/KERATOMETER]

04987669101476The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors an
04987669100745The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cyl
04987669100738The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cyl
04987669100721The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refractive errors, a
04987669100714The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refractive errors, a
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