| Primary Device ID | 03700512977971 |
| NIH Device Record Key | df3bc3af-7c9f-46e4-85e6-e85f81be6951 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OlyCath Curved 0 Eye 5 French |
| Version Model Number | ROTH5000ST245 |
| Catalog Number | OLCAC05 |
| Company DUNS | 401020409 |
| Company Name | Promepla |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |