Palmaz Genesis

FDA UDI

Class II (US FDA UDI)

by Cordis US Corp.

Identity

Trade Name: Palmaz Genesis FDA UDI
Generic Name: Bare-metal biliary stent FDA UDI
Device Name: STENT GENESIS XD 39MM FDA UDI
Model / Reference: PG3910B FDA UDI
Description: STENT GENESIS XD 39MM FDA UDI

Identifiers

Catalog Number: PG3910B FDA UDI
Primary DI / UDI-DI: 20705032057544 FDA UDI
510(k) Number: K020809 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

Palmaz Genesis 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

K020809 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 486c7b3d-a1a4-4d71-84e5-351c89b8b95b 36 fields · synced May 31, 2026