LINX Reflux Management System

GUDID 00855106005325

Torax Medical, Inc.

Gastro-oesophageal antireflux prosthesis

• Primary Device ID: 00855106005325
• NIH Device Record Key: 47e14128-600c-463a-90be-1b399b488905
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINX Reflux Management System
• Version Model Number: LXMC12
• Company DUNS: 137949538
• Company Name: Torax Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855106005325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100049

FDA Product Code

• LEI: Implant, Anti-Gastroesophageal Reflux

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-31
• Device Publish Date: 2015-05-13

On-Brand Devices [LINX Reflux Management System]

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