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
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24
00884450277652Safety Paracentesis Procedure TrayInitial ReleaseSPPT-8F-10S2026-09-22
00884450416723SureCrossDSC18652026-09-22
00884450422755SureCrossDSC14902026-09-22
00884450423110SureCrossDSC14652026-09-22
00884450427170SureCrossDSC141352026-09-22
00884450428016Merit Medical®Initial ReleaseK10-03360H2026-09-22
00884450435526Merit Medical®Initial ReleaseK09-11159A2026-09-22
00884450445419Merit Medical®Initial ReleaseK09-01589X2026-09-22
00884450473313Merit Medical®Initial ReleaseK09-14357A2026-09-22
00884450852279Merit Medical®Initial ReleasePC8112026-09-22
00884450852286Merit Medical®Initial ReleasePC8122026-09-22
10884450489809Prelude SNAP™APLSX-25112026-09-22
10884450489816Prelude SNAP™APLSS-10062026-09-22
10884450489823Prelude SNAP™APLSS-10072026-09-22

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