Zilver Vena
- Primary DI
- 10827002574370
- Company
- COOK IRELAND LTD
- Model
- G57437
- Catalog number
- ZVT7-35-120-10-60
- Device description
- Zilver Vena, Venous Self-Expanding Stent
- Published
- 2020-11-04
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 988559035
- 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
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10827002574370 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 10827002574370 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| QAN | Stent, Iliac Vein | 3 | Unknown | | Y | Ineligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
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. |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Do not store outside the temperature range of 2 Degrees C to 40 Degrees C (36 Degrees F to 104 Degrees F). Store in a dark, dry, cool place. Avoid extended exposure to light. |
| Storage Environment Temperature | 2 Degrees Celsius | 40 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +1(812)330-5494 | sharedservices@cookmedical.com |
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