Duo Venous Stent System
- Primary DI
- 00810010693327
- Brand
- Duo Venous Stent System
- Company
- Vesper Medical Inc
- Model
- N1201408009120
- Catalog number
- N1201408009120
- Device description
- Duo Extend Venous Stent System, 14mm x 80mm Stent, 9F x 120cm Delivery System
- Published
- 2024-05-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| QAN | Stent, Iliac Vein |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QAN | Stent, Iliac Vein | Unknown | 3 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P230021 | 000 | | | 1969-12-31 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810010693327 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Iliofemoral vein stent | A non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device 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. |
Regulatory Flags
- DUNS number
- 080441571
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00810010693266 | Duo Venous Stent System | N1201208009120 | N1201208009120 | 2024-05-01 |
| 00810010693280 | Duo Venous Stent System | N1201212009120 | N1201212009120 | 2024-05-01 |
| 00810010693341 | Duo Venous Stent System | N1201412009120 | N1201412009120 | 2024-05-01 |
| 00810010693440 | Duo Venous Stent System | N1101410009120 | N1101410009120 | 2024-05-01 |
| 00810010693457 | Duo Venous Stent System | N1101412009120 | N1101412009120 | 2024-05-01 |
| 00810010693464 | Duo Venous Stent System | N1101414009120 | N1101414009120 | 2024-05-01 |
| 00810010693471 | Duo Venous Stent System | N1101416009120 | N1101416009120 | 2024-05-01 |
| 00810010694782 | Duo Venous Stent System | N1201612010120 | N1201612010120 | 2024-05-01 |
| 00810010694829 | Duo Venous Stent System | N1101610010120 | N1101610010120 | 2024-05-01 |
| 00810010694836 | Duo Venous Stent System | N1101612010120 | N1101612010120 | 2024-05-01 |
| 00810010694843 | Duo Venous Stent System | N1101614010120 | N1101614010120 | 2024-05-01 |
| 00810010694850 | Duo Venous Stent System | N1101616010120 | N1101616010120 | 2024-05-01 |
| 00810010694898 | Duo Venous Stent System | N1101812010120 | N1101812010120 | 2024-05-01 |
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