| Primary Device ID | 04987669101124 |
| NIH Device Record Key | 87c0b025-d174-4f69-b0a1-3e75329e73e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Attachable delivery unit (SL130) |
| Version Model Number | GDA01 |
| 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 | 04987669101124 [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 |
| 04987669101124 | The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the photo |
| 04987669100899 | The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photoc |
| 04987669100240 | The Attachable Delivery Unit (for ZEISS SL130) (hereafter called “attachable delivery unit”) |
| 04987669100141 | The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (hereafter called Zeis |