| Primary Device ID | 04987669200773 | 
| NIH Device Record Key | 68067a7c-88dd-489f-84a7-e4fc0f67b438 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AL-Scan Viewer for NAVIS-EX | 
| Version Model Number | 1.3 | 
| 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 | true | 
| Serial Number | false | 
| 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 | 04987669200773 [Primary] | 
| NFJ | System, Image Management, 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 | 2023-06-20 | 
| Device Publish Date | 2023-06-12 | 
| 04987669101360 | The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to ha | 
| 04987669200773 | The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to ha |