| Primary Device ID | 04987669100691 |
| NIH Device Record Key | be6eaa4c-fa35-46b8-9644-327221fa437b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AUTO REFRACTOMETER |
| Version Model Number | AR-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 | 04987669100691 [Primary] |
| HKO | Refractometer, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2018-04-20 |
| 04987669101469 | The AUTO REFRACTOMETER AR-F is a medical device which measures objective refractive errors of th |
| 04987669100707 | The NIDEK AUTO REFRACTOMETER AR-1s measures spherical, cylindrical refractive errors, and cylind |
| 04987669100691 | The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and c |
| 04987669100684 | The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and c |