FDA.reportPublic FDA data

SerosaFuse®

Primary DI
00884450848135
Brand
SerosaFuse®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
R2275
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODEEndoscopic suture/plication system, gastroesophageal reflux disease (gerd)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450848135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450848135008844508481358844508481350884450848135

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-oesophageal antireflux intraluminal fundoplication clipAn implantable device designed to be transorally inserted during an endoscopic procedure to secure the stomach fundus to the oesophagus above the gastro-oesophageal junction to create a partial intraluminal fundoplication for the prevention of gastro-oesophageal reflux. It is made of non-bioabsorbable synthetic polymer materials and is typically supplied in a cartridge containing multiple clips/fasteners; a dedicated endoscopic implantation tool may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Kit
true
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
00884450848111EsophyX® Z+Merit Medical Systems, Inc.ODE2026-01-14
00884450848128SerosaFuse®Merit Medical Systems, Inc.ODE2026-01-14
00810275014011SerosaFuse® Implantable Fastener KitENDOGASTRIC SOLUTIONS, INC.ODE2019-03-14
00810275013052SerosaFuse® 7.5mm Implantable Fastener CartridgesENDOGASTRIC SOLUTIONS, INC.ODE2019-03-13
00810275011089EsophyX Z+ENDOGASTRIC SOLUTIONS, INC.ODE2017-11-16
07290014036062MUSE EndostaplerMEDIGUS LTDODE2016-09-20
07290014036529MUSE ConsoleMEDIGUS LTDODE2016-09-20
00810275011065EsophyX2 HDENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
00810275011072EsophyX ZENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130146.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130217.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130386.5mm & 7.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
07290014036079MUSE Staple CartridgeMEDIGUS LTDODE2015-09-24