| Primary Device ID | 04987669100219 |
| NIH Device Record Key | b927189b-7437-4623-8278-f7ac92018402 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Slit lamp delivery unit (SL-1800) |
| Version Model Number | 17421-0000 |
| Company DUNS | 690635461 |
| Company Name | NIDEK CO.,LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987669100219 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-06-24 |
| 04987669100868 | The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photoc |
| 04987669100219 | This delivery unit is connected to the GYC-1000 main body to comprise the photocoagulation syste |
| 04987669100097 | This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main |