| Primary Device ID | 06971591762612 |
| NIH Device Record Key | 0216dd2b-f0cd-4504-8efb-a2ba21ff108b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Selethru PTCA Balloon Dilatation Catheter |
| Version Model Number | KPTCA350030 |
| Company DUNS | 560219894 |
| Company Name | Kossel Medtech (Suzhou) 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 | true |
| OTC Over-The-Counter | false |