| Primary Device ID | 06942265520807 |
| NIH Device Record Key | dd1c006f-1e83-4b63-855f-c628687f1e62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Parafleet SC 035 PTA Balloon Dilatation Catheter |
| Version Model Number | rev 02 |
| Catalog Number | F35-060200-200 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06942265520807 [Primary] |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-21 |
| Device Publish Date | 2025-05-13 |
| 06942265520951 | rev 02 |
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| 06942265520807 | rev 02 |