| Primary Device ID | 04987669203477 |
| NIH Device Record Key | afee5d99-7b32-4bfe-8dd3-972344756006 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTICAL BIOMETER |
| Version Model Number | AL-Scan |
| Catalog Number | 39NNNN |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987669203477 [Primary] |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-20 |
| Device Publish Date | 2023-06-12 |
| 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 |