Identity
- Trade Name
- COOK FDA UDI
- Generic Name
- Bare-metal aortic stent FDA UDI
- Device Name
- Zenith, Dissection Endovascular Stent, With the Z-Trak Plus Introduction System FDA UDI
- Model / Reference
- G47491 FDA UDI
- Description
- Zenith, Dissection Endovascular Stent, With the Z-Trak Plus Introduction System FDA UDI
Identifiers
- Catalog Number
- ZDES-36-80-US FDA UDI
- Primary DI / UDI-DI
- 10827002474915 FDA UDI
- PMA Number
- P180001 FDA UDI
- FDA Product Code
- MIH FDA UDI
- GMDN Term
- Bare-metal aortic 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 aortic stent
Cook by William Cook Europe ApS — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal aortic stent.
- G-ARMOR STENT® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- G-ARMOR STENT® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- G-ARMOR STENT® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- G-ARMOR STENT® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
Cleared under the same submission
P180001 also covers:
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
- COOK — William Cook Europe ApS
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
- William Cook Europe ApS
Sources (1)
- FDA UDI dfb48605-1646-4790-91f7-b25ac59b6a39 37 fields · synced Jun 8, 2026