Home GUDID 00810275011089 EsophyX Z+
Primary DI 00810275011089
Brand EsophyX Z+
Company ENDOGASTRIC SOLUTIONS, INC.
Model R2007
Catalog number R2007
Device description EsophyX Z+ Fastener Delivery Device with SerosaFuse Fasteners and Accessories
Published 2017-11-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810275011089 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810275011089 00810275011089 810275011089 0810275011089
GMDN Terms# Term, Definition table Term Definition Endoscopic suturing unit, single-use A sterile, manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a single-use device.
Regulatory Flags# DUNS number 143602659 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884450848135 SerosaFuse® Merit Medical Systems, Inc. ODE 2026-02-03 00884450848111 EsophyX® Z+ Merit Medical Systems, Inc. ODE 2026-01-14 00884450848128 SerosaFuse® Merit Medical Systems, Inc. ODE 2026-01-14 00810275014011 SerosaFuse® Implantable Fastener Kit ENDOGASTRIC SOLUTIONS, INC. ODE 2019-03-14 00810275013052 SerosaFuse® 7.5mm Implantable Fastener Cartridges ENDOGASTRIC SOLUTIONS, INC. ODE 2019-03-13 07290014036062 MUSE Endostapler MEDIGUS LTD ODE 2016-09-20 07290014036529 MUSE Console MEDIGUS LTD ODE 2016-09-20 00810275011065 EsophyX2 HD ENDOGASTRIC SOLUTIONS, INC. ODE 2015-10-24 00810275011072 EsophyX Z ENDOGASTRIC SOLUTIONS, INC. ODE 2015-10-24 00810275013014 6.5mm Cartridge ENDOGASTRIC SOLUTIONS, INC. ODE 2015-10-24 00810275013021 7.5mm Cartridge ENDOGASTRIC SOLUTIONS, INC. ODE 2015-10-24 00810275013038 6.5mm & 7.5mm Cartridge ENDOGASTRIC SOLUTIONS, INC. ODE 2015-10-24 07290014036079 MUSE Staple Cartridge MEDIGUS LTD ODE 2015-09-24
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