EsophyX2 HD

GUDID 00810275011065

EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories

ENDOGASTRIC SOLUTIONS, INC.

Endoscopic suturing unit, single-use
Primary Device ID00810275011065
NIH Device Record Key1464a5cf-54a3-4304-9c42-be55477b61ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsophyX2 HD
Version Model NumberR2005
Company DUNS143602659
Company NameENDOGASTRIC SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone425-307-9269
Emailcustomerservice@endogastricsolutions.com
Phone425-307-9269
Emailcustomerservice@endogastricsolutions.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810275011065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

Devices Manufactured by ENDOGASTRIC SOLUTIONS, INC.

00810275014011 - SerosaFuse® Implantable Fastener Kit2019-03-22 Single kit consists of 1 each R2007 EsophyX Z+ Fastener Delivery Device and 1 each R2375 SerosaFuse Implantable Fastener Cartrid
00810275013052 - SerosaFuse® 7.5mm Implantable Fastener Cartridges2019-03-21 2 Cartridges, 40 Implantable Fasteners, 7.5mm Web Length
00810275011065 - EsophyX2 HD2018-07-06EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories
00810275011065 - EsophyX2 HD2018-07-06 EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories
00810275011072 - EsophyX Z2018-07-06 EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories
00810275013014 - 6.5mm Cartridge2018-07-06 Cartridge, 20 Fasteners, 0.010" Slot, 6.5mm Web
00810275013021 - 7.5mm Cartridge2018-07-06 Cartridge, 20 Fasteners, 0.010" Slot, 7.5mm Web
00810275013038 - 6.5mm & 7.5mm Cartridge2018-07-06 Cartridge, 40 Implantable Fasteners, 6.5mm & 7.5mm Web Length
00810275011089 - EsophyX Z+2018-03-29 EsophyX Z+ Fastener Delivery Device with SerosaFuse Fasteners and Accessories

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