| Primary Device ID | 04987669101452 |
| NIH Device Record Key | f163362f-1b11-4d31-bfed-eb037c9089ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ophthalmic YAG Laser System |
| Version Model Number | YC-200 |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com | |
| Phone | 1-800-223-9044 |
| info@nidek.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987669101452 [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 | 2021-10-04 |
| Device Publish Date | 2021-09-24 |
| 04987669100073 | The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) p |
| 04987669101452 | The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main |