| Primary Device ID | 00811311021031 |
| NIH Device Record Key | a5f4fafd-29b7-43c5-b558-522b7dc84937 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter |
| Version Model Number | SR-6035-BC |
| Catalog Number | SR-6035-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 |
| Phone | 1-855-410-8227 |
| customerservice@silkroadmed.com | |
| Phone | 1-855-410-8227 |
| customerservice@silkroadmed.com | |
| Phone | 1-855-410-8227 |
| customerservice@silkroadmed.com | |
| Phone | 1-855-410-8227 |
| customerservice@silkroadmed.com | |
| Phone | 1-855-410-8227 |
| customerservice@silkroadmed.com | |
| Phone | 1-855-410-8227 |
| customerservice@silkroadmed.com | |
| Phone | 1-855-410-8227 |
| customerservice@silkroadmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811311021031 [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 | 2022-11-10 |
| Device Publish Date | 2022-11-02 |
| 00811311021031 | 6mmx35mm |
| 00811311021024 | 5.5mmx35mm |
| 00811311020966 | 6mm X 25mm |
| 00811311020959 | 5.5mm X 25mm |