OPHTHALMOSCOPE

GUDID 04987669100561

The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red.

NIDEK CO.,LTD.

Direct ophthalmoscope, line-powered
Primary Device ID04987669100561
NIH Device Record Key3091c2ad-24bd-4c94-b662-9f7c14c6c796
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPHTHALMOSCOPE
Version Model NumberF-10
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987669100561 [Primary]

FDA Product Code

MYCOphthalmoscope, Laser, Scanning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-21
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

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