Home GUDID 05350646999912 RefluxStop Deployment Tool
Primary DI 05350646999912
Brand RefluxStop Deployment Tool
Company IMPLANTICA CE REFLUX LTD
Model RS-300
Device description Gastro-oesophageal antireflux fundal implant placement tool
Published 2026-10-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LEI Implant, Anti-Gastroesophageal Reflux
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LEI Implant, Anti-Gastroesophageal Reflux Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05350646999912 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05350646999912 05350646999912 5350646999912
GMDN Terms# Term, Definition table Term Definition Gastro-oesophageal antireflux fundal implant placement tool, reusable An 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 reusable device.
Sterilization Methods# Method table Method High-level Disinfectant
Regulatory Flags# DUNS number 533998189 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05350646999905 RefluxStop RS-A1 2026-10-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05350646999905 RefluxStop IMPLANTICA CE REFLUX LTD LEI 2026-10-22 00855106005325 LINX Reflux Management System Torax Medical, Inc. LEI 2015-05-13 00855106005332 LINX Torax Medical, Inc. LEI 2015-05-13 00855106005349 LINX Torax Medical, Inc. LEI 2015-05-13 00855106005356 LINX Torax Medical, Inc. LEI 2015-05-13 00855106005363 LINX Torax Medical, Inc. LEI 2015-05-13 00855106005370 LINX Torax Medical, Inc. LEI 2015-05-13 00855106005219 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005011 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005028 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005035 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005042 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005059 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005066 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005134 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005141 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005158 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005165 LINX Torax Medical, Inc. LEI 2014-09-10 00855106005226 LINX Esophagus Sizing Tool Torax Medical, Inc. LEI 2014-09-10 00855106005172 LINX Torax Medical, Inc. LEI 2014-09-09 00855106005189 LINX Torax Medical, Inc. LEI 2014-09-09
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