Alimaxx-B®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: ALIMAXX-B® FDA UDI
Generic Name: Bare-metal biliary stent FDA UDI
Model / Reference: 00884450031094 FDA UDI

Identifiers

Catalog Number: 70129-209/C FDA UDI
Primary DI / UDI-DI: 00884450031094 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

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

The ALIMAXX-B® is a non-bioabsorbable, bare-metal biliary stent designed to maintain luminal patency in obstructed biliary ducts. This metal stent is suitable for use in the common bile duct and may be expandable or disposable.

Similar devices

Also classified as Bare-metal biliary stent.

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System — Cordis US Corp. · Class II
LifeStar® Biliary Stent — Bard Peripheral Vascular · Class II
SMART FLEX — Cordis US Corp. · Class II
BONASTENT® Biliary — Sewoon Medical Co., Ltd. · Class II
Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System — Cordis US Corp. · 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

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: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 44662cbb-bb8d-4b84-bb0e-2f7a73b9ff89 34 fields · synced Jul 19, 2026