| Primary Device ID | 00850053428692 |
| NIH Device Record Key | 0e9fa9b2-7784-4294-be30-d0a485b9b030 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OC-2400 |
| Version Model Number | 24048-WH-H1-000 |
| Company DUNS | 053547238 |
| Company Name | TOPCON HEALTHCARE INC |
| 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 | false |
| OTC Over-The-Counter | false |