AccessGUDID - DEVICE: ALIMAXX-ES™ (00884450038581)

GUDID

Device Identifier (DI) Information

Brand Name: ALIMAXX-ES™
Version or Model: 00884450038581
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80129-214/C
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450038581
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61751	Polymer-metal oesophageal stent	A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ESW	PROSTHESIS, ESOPHAGEAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Expanded Stent Length (mm)-100 mm
Device Size Text, specify: Nominal Stent Diameter (mm)-16 mm
Device Size Text, specify: Nominal Stent Diameter (mm)-16 mm; Expanded Stent Length (mm)-100 mm; Nominal Stent Diameter (mm)-16 mm

Device Record Status

Public Device Record Key: 72a8a368-a22c-4532-9b9f-30f2d4085ad6
Public Version Date: April 21, 2025
Public Version Number: 5
DI Record Publish Date: October 31, 2015