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: 00884450031100 FDA UDI

Identifiers

Catalog Number: 70129-210/C FDA UDI
Primary DI / UDI-DI: 00884450031100 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

Alimaxx-B® by Merit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal biliary stent.

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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 7ee88474-e3e6-4429-ac02-1aac976fba55 34 fields · synced Jun 9, 2026