AUTO REFRACTOMETER

GUDID 04987669101469

The AUTO REFRACTOMETER AR-F is a medical device which measures objective refractive errors 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.

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Primary Device ID04987669101469
NIH Device Record Key7b6312f2-a0a9-4753-bb57-3b77a0a92b3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTO REFRACTOMETER
Version Model NumberAR-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
GS104987669101469 [Primary]

FDA Product Code

HKORefractometer, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-02-22

On-Brand Devices [AUTO REFRACTOMETER]

04987669101469The AUTO REFRACTOMETER AR-F is a medical device which measures objective refractive errors of th
04987669100707The NIDEK AUTO REFRACTOMETER AR-1s measures spherical, cylindrical refractive errors, and cylind
04987669100691The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and c
04987669100684The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and c

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