| Primary Device ID | 00811311020928 |
| NIH Device Record Key | 28de6720-c13d-49e8-b82b-2e3f460857ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter |
| Version Model Number | SR-4025-BC |
| Catalog Number | SR-4025-BC |
| Company DUNS | 022516829 |
| Company Name | SILK ROAD MEDICAL, INC. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811311020928 [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 | 2022-11-03 |
| Device Publish Date | 2022-10-26 |
| 00811311020935 - ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | 2024-10-25 4.5mm X 25mm |
| 00811311020942 - ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | 2024-10-25 5mm X 25mm |
| 00811311020997 - ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | 2024-10-25 4mm X 35mm |
| 00811311021000 - ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | 2024-10-25 4.5mm X 35mm |
| 00811311021017 - ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | 2024-10-25 5mm X 35mm |
| 00811311021260 - ENROUTE Transcarotid Stent | 2023-06-30 8-6mm x 30mm |
| 00811311021277 - ENROUTE Transcarotid Stent | 2023-06-30 8-6mm x 40mm |
| 00811311021284 - ENROUTE Transcarotid Stent | 2023-06-30 9-7mm x 30mm |