FDA UDI
In Commercial Distribution
🇺🇸 United States
Carotid WALLSTENT®
DI: 08714729781202
·
Model: M001719020
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Carotid WALLSTENT®
- Primary DI
- 08714729781202
- Version / Model
- M001719020
- Catalog Number
- M001719020
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-24
- Public Version
- 6
- Public Version Date
- 2023-04-17
- Public Version Status
- Update
- Public Device Record Key
- 4f64e59a-2f59-4cd7-9840-f4f222979f88
Device Description
Closed Cell Self-Expanding Stent
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
- No
- 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 | 08714729781202 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P050019 | 000 |
| P050019 | 001 |
| P050019 | 004 |
| P050019 | 006 |
| P050019 | 008 |
| P050019 | 021 |
| P050019 | 035 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 135 cm Effective Length | ||
| Device Size Text, specify | 29 mm Stent Length | ||
| Device Size Text, specify | 8 mm Stent Diameter |