Identity
- Trade Name
- Formula FDA UDI
- Generic Name
- Peripheral artery stent, bare-metal FDA UDI
- Device Name
- Formula 414 Rx, Renal Balloon-Expandable Stent FDA UDI
- Model / Reference
- G56971 FDA UDI
- Description
- Formula 414 Rx, Renal Balloon-Expandable Stent FDA UDI
Identifiers
- Catalog Number
- FORX414-14-135-6-16 FDA UDI
- Primary DI / UDI-DI
- 10827002569710 FDA UDI
- PMA Number
- P100028 FDA UDI
- FDA Product Code
- NIN FDA UDI
- GMDN Term
- 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
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
Formula by William Cook Europe ApS — 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
- William Cook Europe ApS
Sources (1)
- FDA UDI c95eb04f-2a76-4054-bbb2-764f3edb9aca 38 fields · synced May 31, 2026