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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
PRB35-06-120-080 FDA UDI
Description
Self-Expanding Peripheral Stent System FDA UDI

Identifiers

Primary DI / UDI-DI
00821684042878 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 120 Millimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI
Catheter Gauge — 6 French FDA UDI
Outer Diameter — 6 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.

Cleared under the same submission

P110023 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI dd90657d-5dd4-4080-8b7b-b50fb4c3b6f7 37 fields · synced May 30, 2026