AUTO REF/KERATOMETER

GUDID 04987669100714

Ophthalmic refractometer, automated

Primary Device ID	04987669100714
NIH Device Record Key	6d655660-d58e-455c-be75-aecc3d191dd5
Commercial Distribution Status	In Commercial Distribution
Brand Name	AUTO REF/KERATOMETER
Version Model Number	ARK-1
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	04987669100714 [Primary]

HKO	Refractometer, Ophthalmic

Steralize Prior To Use	false
Device Is Sterile	false

04987669101476	The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors an
04987669100745	The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cyl
04987669100738	The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cyl
04987669100721	The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refractive errors, a
04987669100714	The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refractive errors, a