| Primary Device ID | 04987669101070 | 
| NIH Device Record Key | ff5f5ac8-5a21-4ef8-b382-bb5d18383244 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | DIGITAL MEDICAL SCOPE | 
| Version Model Number | DS-10 Control Unit | 
| 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 | |
| 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 | |
| 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 | 04987669101070 [Primary] | 
| FTT | Camera, Still, Surgical | 
| 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 | 2017-01-31 | 
| 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 |