HANDHELD REFRACTOMETER

GUDID 04987669100752

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.

NIDEK CO.,LTD.

Ophthalmic refractometer, automated Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer
Primary Device ID04987669100752
NIH Device Record Key3e46968d-f608-4e18-8ea5-295fe38eb41f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANDHELD REFRACTOMETER
Version Model NumberHandyRef
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
GS104987669100752 [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 Date2018-04-20

Devices Manufactured by NIDEK CO.,LTD.

04987669200018 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
04987669200049 - Pachymetry probe (45° fixed type)2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
04987669200070 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200094 - Pachymetry probe2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200100 - Pachymetry probe (45° fixed type)2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200117 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.
04987669200780 - IOL-Station2023-07-18 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica
04987669100844 - IOL-Station2023-06-20 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.