Identity
- Trade Name
- EverFlex™ FDA UDI
- Generic Name
- Peripheral artery stent, bare-metal FDA UDI
- Device Name
- STENT EVD35-06-020-120 EF ENTRUST V01 FDA UDI
- Model / Reference
- EVD35-06-020-120 FDA UDI
- Description
- STENT EVD35-06-020-120 EF ENTRUST V01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684051337 FDA UDI
- PMA Number
- P110023 FDA UDI
- FDA Product Code
- NIP FDA UDI
- GMDN Term
- Peripheral artery stent, bare-metal 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 20.0 Millimeter FDA UDICatheter Gauge — 5.0 French FDA UDI
Category: Peripheral artery stent, bare-metal
EverFlex™ by Covidien LP — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral artery stent, bare-metal.
- Innova™ Vascular — Boston Scientific · Class III
- Pulsar-18 — Biotronik, Inc. · Class III
- LifeStent® Solo Vascular Stent — Bard Peripheral Vascular · Class III
- Astron — Biotronik, Inc. · Class III
- Absolute Pro — Abbott Vascular · Class III
- Protégé™ GPS™ — EV3, INC · Class II
- COMPLETE® SE VASCULAR — MEDTRONIC, INC. · Class III
- Zilver 518 — Cook Ireland, Ltd. · Class III
Cleared under the same submission
P110023 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 30370a99-c5bc-47be-9583-eab760f39f24 37 fields · synced Jun 1, 2026