Home GUDID 05350646999905 RefluxStop
Primary DI 05350646999905
Brand RefluxStop
Company IMPLANTICA CE REFLUX LTD
Model RS-A1
Device description GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES
Published 2026-10-22
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile true
Single use true
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 15350646999902 Package GS1 1 In Commercial Distribution 25350646999909 Package GS1 2 In Commercial Distribution 05350646999905 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 15350646999902 15350646999902 25350646999909 25350646999909 05350646999905 05350646999905 5350646999905
GMDN Terms# Term, Definition table Term Definition Gastro-oesophageal antireflux extraluminal fundal implant An implantable device incorporated into an extraluminal invagination of the stomach fundus to provide a solid space-occupying mass when the fundus is tethered to the lower oesophagus, for the prevention of hiatal hernia and gastro-oesophageal reflux. It is made of silicone and is implanted during a laparoscopic procedure using a dedicated tool (not included).
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 false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05350646999912 RefluxStop Deployment Tool RS-300 2026-10-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05350646999912 RefluxStop Deployment Tool 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