| Primary Device ID | 04987669100813 |
| NIH Device Record Key | c3f986af-1115-4dc3-af5f-434adb47dd45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REFRACTOR |
| Version Model Number | RT-3100 |
| 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 | 04987669100813 [Primary] |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-21 |
| Device Publish Date | 2018-04-20 |
| 04987669100820 | The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in |
| 04987669100813 | The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction wit |
| 04987669101445 | The RT-6100 is a motorized refractor for subjective refraction designed to be connected with oth |
| 04987669101711 | NIDEK Model RT-600 has been developed to renovate the conventional refractor, assuming a new asp |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REFRACTOR 75404035 2216412 Live/Registered |
TOPPS COMPANY, INC., THE 1997-12-11 |