EndoMAXX®

Basic Information

• Brand Name: EndoMAXX®
• Primary DI: 00884450093085
• Version / Model: 00884450093085
• Catalog Number: MAXX-1915/C
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-31
• Public Version: 4
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: b6305e37-09a4-464a-872a-0a055ccf004a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ESW	PROSTHESIS, ESOPHAGEAL	General, Plastic Surgery	878.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61570	Polymer-metal oesophageal stent, non-sterile	A non-sterile, 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884450093082	GS1		1	In Commercial Distribution
Primary	00884450093085	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Nominal Stent Diameter (mm)-19 mm
Device Size Text, specify			Expanded Stent Length (mm)-150 mm