| Primary Device ID | 00811311021260 |
| NIH Device Record Key | 60de2826-a0c6-474b-a4b6-295a0fce74ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENROUTE Transcarotid Stent |
| Version Model Number | FG11815 |
| Catalog Number | SR-080630-TCS |
| Company DUNS | 022516829 |
| Company Name | SILK ROAD MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00811311021260 [Primary] |
| NIM | Stent, Carotid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-30 |
| Device Publish Date | 2023-06-22 |
| 00811311020539 | 10 mm X 40 mm |
| 00811311020522 | 10 mm X 30 mm |
| 00811311020515 | 10 mm X 20 mm |
| 00811311020508 | 9 mm X 40 mm |
| 00811311020492 | 9 mm X 30 mm |
| 00811311020485 | 9 mm X 20 mm |
| 00811311020478 | 8 mm X 40 mm |
| 00811311020461 | 8 mm X 30 mm |
| 00811311020454 | 8 mm X 20 mm |
| 00811311020447 | 7 mm X 40 mm |
| 00811311020430 | 7 mm X 30 mm |
| 00811311020423 | 7 mm X 20 mm |
| 00811311020416 | 6 mm X 40 mm |
| 00811311020409 | 6 mm X 30 mm |
| 00811311020393 | 6 mm X 20 mm |
| 00811311020386 | 5 mm X 40 mm |
| 00811311020379 | 5 mm X 30 mm |
| 00811311020362 | 5 mm X 20 mm |
| 00811311021321 | 10-7mm x 40mm |
| 00811311021314 | 10-8mm x 40mm |
| 00811311021307 | 10-8mm x 30mm |
| 00811311021291 | 9-7mm x 40mm |
| 00811311021284 | 9-7mm x 30mm |
| 00811311021277 | 8-6mm x 40mm |
| 00811311021260 | 8-6mm x 30mm |