EverFlex™ Protégé™ EverFlex™

FDA UDI

Class III (US FDA UDI)

by Ev3, Inc

Identity

Trade Name: EverFlex™ Protégé™ EverFlex™ FDA UDI
Generic Name: Peripheral artery stent, bare-metal FDA UDI
Device Name: STENT PRB35-07-200-120 PROTEGE EF V07 FDA UDI
Model / Reference: PRB35-07-200-120 FDA UDI
Description: STENT PRB35-07-200-120 PROTEGE EF V07 FDA UDI

Identifiers

Primary DI / UDI-DI: 00821684060162 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 200.0 Millimeter FDA UDI
Catheter Gauge — 6.0 French FDA UDI

Category: Peripheral artery stent, bare-metal

EverFlex™ Protégé™ EverFlex™ by Ev3, Inc — 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
COMPLETE® SE VASCULAR — MEDTRONIC, INC. · Class III
Zilver 518 — Cook Ireland, Ltd. · Class III
Supera™ — Abbott Vascular · 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: Ev3, Inc

Sources (1)

FDA UDI e5a6603c-7709-43a5-aeaa-71a0399d72b0 37 fields · synced Jun 6, 2026