Home GUDID 00855106005226 LINX Esophagus Sizing Tool
Primary DI 00855106005226
Brand LINX Esophagus Sizing Tool
Company Torax Medical, Inc.
Model LSSUS
Published 2014-09-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00855106005226 Primary GS1 0 00855106005219 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00855106005226 00855106005226 855106005226 0855106005226 00855106005219 00855106005219 855106005219 0855106005219
GMDN Terms# Term, Definition table Term Definition Gastro-oesophageal antireflux prosthesis An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. It typically consists of a toroidal, C-shaped elastomer ring filled with a silicone gel that includes a polyester tie to secure the ring around the gastro-oesophageal junction; it is intended for surgical implantation under the diaphragm to hold the lower oesophagus in place as an alternative to traditional surgical fixation of the stomach (i.e., gastropexy) or fundoplication. This GMDN code may reflect old technology.
Regulatory Flags# DUNS number 137949538 Device count 5 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 00855106005172 LINX Torax Medical, Inc. LEI 2014-09-09 00855106005189 LINX Torax Medical, Inc. LEI 2014-09-09