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Protégé™ GPS™

FDA UDI

Class III (US FDA UDI)

by Ev3, Inc

Identity

Trade Name
Protégé™ GPS™ FDA UDI
Generic Name
Peripheral artery stent, bare-metal FDA UDI
Device Name
STENT SERB65-10-20-80 PROTEGE GPS V06 FDA UDI
Model / Reference
SERB65-10-20-80 FDA UDI
Description
STENT SERB65-10-20-80 PROTEGE GPS V06 FDA UDI

Identifiers

Primary DI / UDI-DI
00643169729018 FDA UDI
PMA Number
P060001 FDA UDI
FDA Product Code
NIO FDA UDI
FGE FDA UDI
GMDN Term
Peripheral artery stent, bare-metal FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
876.5010 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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6.0 French FDA UDI
Length — 20.0 Millimeter FDA UDI

Category: Peripheral artery stent, bare-metal

Protégé™ GPS™ 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.

Cleared under the same submission

P060001 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 74d22cf1-adab-4ab5-9b1a-3a0c53b545b3 37 fields · synced May 31, 2026