| Primary Device ID | 04987669100547 | 
| NIH Device Record Key | 2376551d-fd58-429f-a93c-0f3d5806dc81 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | OPTICAL BIOMETER | 
| Version Model Number | AL-Scan | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04987669100547 [Primary] | 
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 
| 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 | 2016-08-26 | 
| 04987669100547 | The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values | 
| 04987669203651 | The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as | 
| 04987669203477 | The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as |