S.m.a.r.t.

FDA UDI

Class II (US FDA UDI)

by Cordis US Corp.

Identity

Trade Name: S.M.A.R.T. FDA UDI
Generic Name: Bare-metal biliary stent FDA UDI
Device Name: PKG ASSY 10X080 SMART BIL 80CM FDA UDI
Model / Reference: C10080SB FDA UDI
Description: PKG ASSY 10X080 SMART BIL 80CM FDA UDI

Identifiers

Catalog Number: C10080SB FDA UDI
Primary DI / UDI-DI: 20705032024690 FDA UDI
510(k) Number: K042969 FDA UDI
FDA Product Code: FGE FDA UDI
GMDN Term: Bare-metal biliary stent FDA UDI

Classification

Device Class: Class II 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

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

Category: Bare-metal biliary stent

S.m.a.r.t. by Cordis US Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal biliary stent.

ALIMAXX-B® — Merit Medical Systems, Inc. · Class II
LifeStar® Biliary Stent — Bard Peripheral Vascular · Class II
BONASTENT® Biliary — Sewoon Medical Co., Ltd. · Class II
Valeo® Balloon Expandable Biliary Stent — Bard Peripheral Vascular · Class II
E·Luminexx® Biliary Stent — Bard Peripheral Vascular · Class II
Protégé™ GPS™ — EV3, INC · Class II
LifeStent® XL Vascular & Biliary Stent — Bard Peripheral Vascular · Class III
Protege GPS — Covidien LP · Class II

Cleared under the same submission

K042969 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 II	Pending data

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Manufacturer

Manufacturer: Cordis US Corp.

Sources (1)

FDA UDI 0d0df758-e9aa-4fa4-b55a-459721e0ac14 35 fields · synced Jun 6, 2026