Identity
- Trade Name
- Zilver Vena FDA UDI
- Generic Name
- Bare-metal peripheral venous stent FDA UDI
- Device Name
- Zilver Vena, Venous Self-Expanding Stent FDA UDI
- Model / Reference
- G57442 FDA UDI
- Description
- Zilver Vena, Venous Self-Expanding Stent FDA UDI
Identifiers
- Catalog Number
- ZVT7-35-120-12-100 FDA UDI
- Primary DI / UDI-DI
- 10827002574424 FDA UDI
- FDA Product Code
- QAN FDA UDI
- GMDN Term
- Bare-metal peripheral venous stent FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Bare-metal peripheral venous stent
Zilver Vena by Cook Ireland, Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal peripheral venous stent.
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
- VICI RDS™ Venous Stent System — Veniti Inc · Class III
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
- Duo Hybrid Venous Stent System — Vesper Medical, Inc. · Class III
- Abre™ — MEDTRONIC, INC. · Class III
- VICI RDS™ Venous Stent System — Veniti Inc · Class III
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA UDI c5733b5e-472f-49d2-a269-44e6299ea088 36 fields · synced Jun 8, 2026