ETHICON Linx Esophagus Sizing Tool LST

GUDID 30855106005432

ETHICON Linx Esophagus Sizing Tool

Torax Medical, Inc.

Gastro-oesophageal antireflux prosthesis
Primary Device ID30855106005432
NIH Device Record Key408ba3f4-d3da-41a1-9f63-78a75d0d6aff
Commercial Distribution StatusIn Commercial Distribution
Brand NameETHICON Linx Esophagus Sizing Tool
Version Model NumberLST
Catalog NumberLST
Company DUNS137949538
Company NameTorax Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110855106005438 [Primary]
GS120855106005435 [Package]
Contains: 10855106005438
Package: BOX [5 Units]
In Commercial Distribution
GS130855106005432 [Package]
Contains: 10855106005438
Package: CASE [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJNLaparoscopic accessories, esophageal sizing

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-31
Device Publish Date2020-12-23

Devices Manufactured by Torax Medical, Inc.

00855106005219 - LINX2021-03-01 LINX Esophagus Sizing Tools
30855106005432 - ETHICON Linx Esophagus Sizing Tool2020-12-31ETHICON Linx Esophagus Sizing Tool
30855106005432 - ETHICON Linx Esophagus Sizing Tool2020-12-31 ETHICON Linx Esophagus Sizing Tool
00855106005226 - LINX Esophagus Sizing Tool2018-12-31
00855106005325 - LINX Reflux Management System2018-12-31
00855106005332 - LINX Reflux Management System2018-12-31
00855106005349 - LINX Reflux Management System2018-12-31
00855106005356 - LINX Reflux Management System2018-12-31
00855106005363 - LINX Reflux Management System2018-12-31

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