| Primary Device ID | 04987669101018 |
| NIH Device Record Key | 06af62a3-6781-4b82-a108-c4b49e404b22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIGITAL MEDICAL SCOPE |
| Version Model Number | DS-10A |
| Company DUNS | 690635461 |
| Company Name | NIDEK CO.,LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 04987669101018 [Primary] |
| FXF | Speculum, Illuminated |
| 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 | 2017-01-27 |
| 04987669101087 | NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and vide |
| 04987669101070 | The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be u |
| 04987669101056 | DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in t |
| 04987669101049 | DS-10G is a digital hand-held camera used to record digital photographs and video of the human b |
| 04987669101032 | DS-10E is a digital hand-held otoscope used to record digital photographs and video of the human |
| 04987669101025 | DS-10D is a digital hand-held dermatoscope used to record digital photographs and video of the h |
| 04987669101018 | DS-10A is a digital hand-held anterior scope used to record digital photographs and video of ant |
| 04987669101001 | NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and vide |
| 04987669100998 | NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and vid |