FDA UDI
In Commercial Distribution
🇺🇸 United States
ELUVIA™
DI: 08714729876595
·
Model: H74939294600810
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELUVIA™
- Primary DI
- 08714729876595
- Version / Model
- H74939294600810
- 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
- 7
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- b06ae13f-4c38-42e1-be40-b0070b2fcbde
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, and intracranial arteries) to maintain luminal patency typically in patients with symptomatic peripheral artery disease; it is not dedicated to carotid artery implantation. 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 | 08714729876595 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180011 | 000 |
| P180011 | 011 |
| P180011 | 025 |
| P180011 | 028 |
| P180011 | 046 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 130 | Centimeter | |
| Outer Diameter | 6 | Millimeter | |
| Length | 80 | Millimeter |