Identity
- Trade Name
- Zilver PTX FDA UDI
- Generic Name
- Drug-eluting peripheral artery stent, bare-metal FDA UDI
- Device Name
- Zilver PTX, Drug-Eluting Peripheral Stent FDA UDI
- Model / Reference
- G24914 FDA UDI
- Description
- Zilver PTX, Drug-Eluting Peripheral Stent FDA UDI
Identifiers
- Catalog Number
- ZIV6-35-125-8-60-PTX FDA UDI
- Primary DI / UDI-DI
- 10827002249148 FDA UDI
- FDA Product Code
- NIU FDA UDI
- GMDN Term
- Drug-eluting peripheral artery stent, bare-metal FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Zilver PTX by Cook Ireland, Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 64b1ca70-a9a0-4adb-baeb-ee38b98a91fd 37 fields · synced May 31, 2026