FDA UDI
In Commercial Distribution
🇺🇸 United States
ENROUTE Transcarotid Stent
DI: 00811311021291
·
Model: FG11815
·
SILK ROAD MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENROUTE Transcarotid Stent
- Primary DI
- 00811311021291
- Version / Model
- FG11815
- Catalog Number
- SR-090740-TCS
- Company Name
- SILK ROAD MEDICAL, INC.
- Labeler DUNS
- 022516829
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-22
- Public Version
- 1
- Public Version Date
- 2023-06-30
- Public Version Status
- New
- Public Device Record Key
- 2427b8c2-178e-4d3b-966a-22c287798332
Device Description
9-7mm x 40mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIM | Stent, Carotid | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45851 | Bare-metal carotid artery stent | A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811311021291 | GS1 |
Customer Contacts
- Phone
- 1-855-410-8227
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140026 | 024 |