FDA.reportPublic FDA data

EndoMAXX®

Primary DI
00884450147641
Brand
EndoMAXX®
Company
Merit Medical Systems, Inc.
Model
00884450147641
Catalog number
MAXX-2315/C
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

Code, Name table
CodeName
ESWPROSTHESIS, ESOPHAGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESWProsthesis, EsophagealGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450147648PackageGS11In Commercial Distribution
00884450147641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445014764810884450147648
00884450147641008844501476418844501476410884450147641

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-metal oesophageal stentA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14
00884450493199Merit Medical®Initial ReleaseK11-014882026-07-14
00884450108765Merit Medical®Initial ReleaseK09-10721A2026-07-10
00884450450949Merit Medical®Initial ReleaseK09-143532026-07-11
00884450487334Merit Medical®Initial ReleaseK11-014852026-07-10
00884450487341Merit Medical®Initial ReleaseK12-127232026-07-10
00884450492956Merit Medical®Initial ReleaseK10T-061782026-07-11
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800026631149HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-29
00884450093580RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093597RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093603RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093627RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093917RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094020RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094037RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094105RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094242RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
08800026612711HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612728HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612735HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612742HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612759HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612766HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612773HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612780HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026631156HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631163HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631170HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631187HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631194HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631200HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631217HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631224HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631231HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631286HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631293HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631989HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22