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EverFlex

FDA UDI

Class II (US FDA UDI)

by Ev3, Inc

Identity

Trade Name
EverFlex FDA UDI
Generic Name
Peripheral artery stent, bare-metal FDA UDI
Device Name
STENT PRB35-07-150-080 PROTEGE EF V10 FDA UDI
Model / Reference
PRB35-07-150-080 FDA UDI
Description
STENT PRB35-07-150-080 PROTEGE EF V10 FDA UDI

Identifiers

Primary DI / UDI-DI
00821684069424 FDA UDI
PMA Number
P110023 FDA UDI
510(k) Number
K060057 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Peripheral artery stent, bare-metal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6.0 French FDA UDI
Length — 150.0 Millimeter FDA UDI

EverFlex by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060057 also covers:

P110023 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ev3, Inc

Sources (1)

  • FDA UDI 7704919f-74d9-44e5-9ca9-a4e84ac3bb03 37 fields · synced Jun 8, 2026