| Primary Device ID | 04987669100981 |
| NIH Device Record Key | 8c882f98-b5b6-494a-96b9-cbf0566b7357 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endophotocoagulation Delivery Unit |
| Version Model Number | 11143-0000(9M5P) |
| 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 | 04987669100981 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-16 |
| Device Publish Date | 2019-09-07 |
| 04987669100301 | This Endophotocoagulation Delivery Unit is used for endophotocoagulation. The delivery unit is c |
| 04987669100981 | The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily co |
| 04987669100974 | The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily co |