Protege RX

FDA UDI

Class III (US FDA UDI)

by Covidien LP

Identity

Trade Name: Protege RX FDA UDI
Generic Name: Bare-metal carotid artery stent FDA UDI
Device Name: Carotid Stent System FDA UDI
Model / Reference: SECX-10-60-135 FDA UDI
Description: Carotid Stent System FDA UDI

Identifiers

Primary DI / UDI-DI: 00821684038680 FDA UDI
PMA Number: P060001 FDA UDI
FDA Product Code: NIM FDA UDI
GMDN Term: Bare-metal carotid artery stent 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 60 Millimeter FDA UDI
Catheter Gauge — 6 French FDA UDI

Category: Bare-metal carotid artery stent

Protege RX by Covidien LP — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal carotid artery stent.

Cordis PRECISE PRO Rx Nitinol Stent System — Cordis US Corp. · Class III
ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
Carotid WALLSTENT® — Boston Scientific · Class III
XACT™ — Abbott Vascular · Class III
ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
XACT™ — Abbott Vascular · Class III
Roadsaver Carotid Atery Stent — MICROVENTION INC. · Class III

Cleared under the same submission

P060001 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 80908173-e81b-43f6-8372-af6173452628 37 fields · synced May 30, 2026