Open-field Refraction System

GUDID 04987669204610

Automated ophthalmic refractometer

Primary Device ID	04987669204610
NIH Device Record Key	2fdf34fa-a847-461b-87c0-d5d91d31b51d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Open-field Refraction System
Version Model Number	PHANTOM
Company DUNS	690635461
Company Name	NIDEK CO.,LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	04987669204610 [Primary]

HKO	Refractometer, Ophthalmic

Steralize Prior To Use	false
Device Is Sterile	false

04987669204917	Control Box is a combined examination device that presents optical targets for both distant and
04987669204610	The PHANTOM is a device that performs objective refraction and subjective refraction for the pat