AUTO REF/KERATO/TONOMETER

GUDID 04987669100066

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.

NIDEK CO.,LTD.

Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered
Primary Device ID04987669100066
NIH Device Record Keye208f396-dfbe-414e-9c05-6d6dcbc9a922
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTO REF/KERATO/TONOMETER
Version Model NumberTONOREF II
Company DUNS690635461
Company NameNIDEK CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104987669100066 [Primary]

FDA Product Code

HKXTonometer, 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 Date2016-06-24

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
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