| Primary Device ID | 04987669101216 |
| NIH Device Record Key | 9aebbfe9-915c-425e-b649-deec2b3ce41c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scan Attachable delivery unit (900BQ) |
| Version Model Number | GEC01 |
| 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 | 04987669101216 [Primary] |
| HQF | Laser, 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 |
| 04987669101216 | The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the photo |
| 04987669100943 | The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photoc |
| 04987669100189 | The scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protectiv |