Primary Device ID | 04987669100721 |
NIH Device Record Key | e75d72ba-1e16-4c06-89de-eca7c184d6c1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AUTO REF/KERATOMETER |
Version Model Number | ARK-1a |
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 |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04987669100721 [Primary] |
HKO | Refractometer, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-03-05 |
Device Publish Date | 2018-04-20 |
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 |