| Primary Device ID | 04987669100806 |
| NIH Device Record Key | fe9ae642-4741-4061-8585-a9804b114d10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SYSTEM TABLE |
| Version Model Number | ST-5100 |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-223-9044 |
| info@nidek.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987669100806 [Primary] |
| HRJ | Table, Instrument, Powered, Ophthalmic |
| 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 |
| 04987669100806 | The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installed. The table all |
| 04987669101490 | The ST-600 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually oper |
| 04987669101483 | The ST-6100 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually ope |