FDA UDI
In Commercial Distribution
🇺🇸 United States
ELUVIA™
DI: 08714729876557
·
Model: H74939294601270
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELUVIA™
- Primary DI
- 08714729876557
- Version / Model
- H74939294601270
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-10
- Public Version
- 10
- Public Version Date
- 2025-11-12
- Public Version Status
- Update
- Public Device Record Key
- ce535907-4dad-413a-8089-e66cc3d5c3cd
Device Description
Drug-Eluting Vascular Stent System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| NIU | Stent, superficial femoral artery, drug-eluting | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46919 | Drug-eluting peripheral artery stent, bare-metal | A non-bioabsorbable metal tubular mesh structure with a drug coating intended to be implanted into a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain luminal patency typically in patients with symptomatic peripheral artery disease; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation (e.g., delivery catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729876557 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180011 | 000 |
| P180011 | 011 |
| P180011 | 025 |
| P180011 | 028 |
| P180011 | 046 |
| P180011 | 052 |
| P180011 | 055 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 6 | Millimeter | |
| Length | 120 | Millimeter | |
| Length | 75 | Centimeter |