| Primary Device ID | 07290107011983 |
| NIH Device Record Key | 3bc10127-7294-485d-a009-7bb96fb46b79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NC Gallant™ PTCA Catheter |
| Version Model Number | NCG350R06US |
| Company DUNS | 600593800 |
| Company Name | MEDINOL 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 | 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 |