AUTO REF/KERATOMETER

GUDID 04987669101476

The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors and corneal curvature radius of the patient’s eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation.

NIDEK CO.,LTD.

Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer Bench-top keratometer
Primary Device ID04987669101476
NIH Device Record Key0a10cbd8-a5de-4a6b-804f-44b63d52287a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTO REF/KERATOMETER
Version Model NumberARK-F
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 Perscriptiontrue
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
GS104987669101476 [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 Number3
Public Version Date2020-03-05
Device Publish Date2019-02-22

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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