| Primary Device ID | 06958481443387 |
| NIH Device Record Key | 2ba68966-8e0a-4e6b-8a23-a87f3452b03b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polux PTA Balloon Dilatation Catheterrev 01 |
| Version Model Number | rev 01 |
| Catalog Number | 818-055010-070U |
| Company DUNS | 421318800 |
| Company Name | BrosMed Medical 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 | 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |