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Alimaxx-Es™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
ALIMAXX-ES™ FDA UDI
Generic Name
Polymer-metal oesophageal stent FDA UDI
Model / Reference
F FDA UDI

Identifiers

Catalog Number
80129-211 FDA UDI
Primary DI / UDI-DI
00884450694091 FDA UDI
FDA Product Code
ESW FDA UDI
GMDN Term
Polymer-metal oesophageal stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Polymer-metal oesophageal stent

The ALIMAXX-ES device is a non-invasive, expandable stent intended to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or treat other lesions causing oesophageal leakage. It consists of a mesh structure made of metal covered with a synthetic polymer material that prevents lateral flow and tissue ingrowth.

Similar devices

Also classified as Polymer-metal oesophageal stent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 50ad6378-6ab1-40a4-b5ea-d0787462a072 34 fields · synced Oct 6, 2026