EverFlex

FDA UDI

Class III (US FDA UDI)

by Covidien LP

Identity

Trade Name: EverFlex FDA UDI
Generic Name: Peripheral artery stent, bare-metal FDA UDI
Device Name: Self-Expanding Peripheral Stent System FDA UDI
Model / Reference: PRB35-06-150-080 FDA UDI
Description: Self-Expanding Peripheral Stent System FDA UDI

Identifiers

Primary DI / UDI-DI: 00821684042885 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 150 Millimeter FDA UDI
Catheter Gauge — 6 French FDA UDI
Outer Diameter — 6 Millimeter FDA UDI
Outer Diameter — 2 Millimeter 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI bae148ee-623e-4bc4-b14d-525a62105222 37 fields · synced Jun 8, 2026