FDA UDI
In Commercial Distribution
🇺🇸 United States
ENROUTE Transcarotid Neuroprotection System
DI: 00811311021062
·
Model: FG12531
·
SILK ROAD MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENROUTE Transcarotid Neuroprotection System
- Primary DI
- 00811311021062
- Version / Model
- FG12531
- Catalog Number
- SR-250-NPS
- Company Name
- SILK ROAD MEDICAL, INC.
- Labeler DUNS
- 022516829
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-24
- Public Version
- 1
- Public Version Date
- 2023-05-02
- Public Version Status
- New
- Public Device Record Key
- fe2302ab-a898-4864-b5cc-345ab4f8415e
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58112 | Carotid artery embolic protection system | An assembly of devices intended to provide cerebrovascular embolic protection during carotid artery angioplasty and stenting procedures. It is available in various configurations and typically includes a sheath/catheter(s), intravascular balloon(s), guidewire, and extracorporeal valves/filters. The assembly is introduced into an artery percutaneously and used to produce blockage of blood through balloon inflation, typically at the carotid bifurcation and internal carotid artery to prevent distal embolization by particulate debris/thrombus and allow removal of debris/thrombus by blood filtration or aspiration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811311021062 | GS1 |
Customer Contacts
- Phone
- 1-855-410-8227
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230402 | 000 |