ETHICON Linx Esophagus Sizing Tool LST

GUDID 30855106005432

ETHICON Linx Esophagus Sizing Tool

Torax Medical, Inc.

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• Primary Device ID: 30855106005432
• NIH Device Record Key: 408ba3f4-d3da-41a1-9f63-78a75d0d6aff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETHICON Linx Esophagus Sizing Tool
• Version Model Number: LST
• Catalog Number: LST
• Company DUNS: 137949538
• Company Name: Torax Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855106005438 [Primary]
GS1	20855106005435 [Package]; Contains: 10855106005438; Package: BOX [5 Units]; In Commercial Distribution
GS1	30855106005432 [Package]; Contains: 10855106005438; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201035

FDA Product Code

• QJN: Laparoscopic accessories, esophageal sizing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-31
• Device Publish Date: 2020-12-23

Devices Manufactured by Torax Medical, Inc.

• 00855106005219 - LINX: 2021-03-01 LINX Esophagus Sizing Tools
• 30855106005432 - ETHICON Linx Esophagus Sizing Tool: 2020-12-31ETHICON Linx Esophagus Sizing Tool
• 30855106005432 - ETHICON Linx Esophagus Sizing Tool: 2020-12-31 ETHICON Linx Esophagus Sizing Tool
• 00855106005226 - LINX Esophagus Sizing Tool: 2018-12-31
• 00855106005325 - LINX Reflux Management System: 2018-12-31
• 00855106005332 - LINX Reflux Management System: 2018-12-31
• 00855106005349 - LINX Reflux Management System: 2018-12-31
• 00855106005356 - LINX Reflux Management System: 2018-12-31
• 00855106005363 - LINX Reflux Management System: 2018-12-31