FDA.reportPublic FDA data

EsophyX® Z+

Primary DI
00884450848111
Brand
EsophyX® Z+
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
R2007
Published
2026-01-14
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
00884450848111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450848111008844508481118844508481110884450848111

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-oesophageal antireflux fundal implant placement tool, single-useAn invasive device designed for the implantation of a gastro-oesophageal antireflux fundal implant (e.g., space-occupying extraluminal implant, intraluminal clip/fastener) used to help prevent hiatal hernia and gastro-oesophageal reflux. It is introduced into the body during a luminal endoscopic (e.g., transoral) or laparoscopic intervention and typically consists of a manually-operated trocar or endoscopic implant grasping/releasing insertion tool. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450848135SerosaFuse®Merit Medical Systems, Inc.ODE2026-02-03
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