FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Duo Hybrid Venous Stent System
DI: 00810010693471
·
Model: N1101416009120
·
Vesper Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Duo Hybrid Venous Stent System
- Primary DI
- 00810010693471
- Version / Model
- N1101416009120
- Catalog Number
- N1101416009120
- Company Name
- Vesper Medical, Inc.
- Labeler DUNS
- 080441571
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-01
- Public Version
- 6
- Public Version Date
- 2025-12-19
- Public Version Status
- Update
- Public Device Record Key
- e9d33de8-7266-41d1-964d-96c19107e084
- Distribution End Date
- 2025-03-17
Device Description
Duo Hybrid Venous Stent System, 14mm x 160mm Stent, 9F x 120cm Delivery System
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
- Yes
- 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 |
|---|---|---|---|---|
| QAN | Stent, Iliac Vein | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58057 | Bare-metal peripheral venous stent | A non-bioabsorbable, tubular device made of metal intended to be implanted in a peripheral (typically the iliac and/or femoral) vein to maintain patency in patients with constrained venous outflow; it is not intended for coronary or intracranial venous stenting. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. It is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. 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 | 00810010693471 | GS1 |