LINX Reflux Management System

GUDID 00855106005332

Torax Medical, Inc.

Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis Gastro-oesophageal antireflux prosthesis
Primary Device ID00855106005332
NIH Device Record Keyfa088a9f-2092-47e6-8e55-958107ded789
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINX Reflux Management System
Version Model NumberLXMC13
Company DUNS137949538
Company NameTorax Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100855106005332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LEIImplant, Anti-Gastroesophageal Reflux

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-31
Device Publish Date2015-05-13

On-Brand Devices [LINX Reflux Management System]

00855106005370LXMC17
00855106005363LXMC16
00855106005356LXMC15
00855106005349LXMC14
00855106005332LXMC13
00855106005325LXMC12

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