| Primary Device ID | 10860036000569 |
| NIH Device Record Key | 5dff9603-80d6-489b-bf43-6b5db1c92b61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endovenous Radiofrequency Ablation (RFA) Catheter |
| Version Model Number | VEN-3-60 |
| Catalog Number | VEN-3-60 |
| Company DUNS | 080926907 |
| Company Name | Vein360 LLC |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860036000562 [Primary] |
| GS1 | 08600360005022 [Previous] |
| GS1 | 10860036000569 [Package] Contains: 00860036000562 Package: Case [10 Units] In Commercial Distribution |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-03 |
| Device Publish Date | 2021-10-26 |
| 08600360005107 | Endovenous Radiofrequency Ablation (RFA) Catheter 7-60 |
| 08600360005022 | Endovenous Radiofrequency Ablation (RFA) Catheter 3-60 |
| 08600360005008 | Endovenous Radiofrequency Ablation (RFA) Catheter 7-100 |
| 10860036000569 | Endovenous Radiofrequency Ablation (RFA) Catheter 3-60 |
| 10860036000552 | Endovenous Radiofrequency Ablation (RFA) Catheter 7-100 |
| 10860036000545 | Endovenous Radiofrequency Ablation (RFA) Catheter 7-60 |