LINX

GUDID 00855106005011

Torax Medical, Inc.

Gastro-oesophageal antireflux prosthesis

• Primary Device ID: 00855106005011
• NIH Device Record Key: e48139d4-655a-4d20-b626-8544c05b3e45
• Commercial Distribution Discontinuation: 2016-10-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LINX
• Version Model Number: LS-[12]
• 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: true
• 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	00855106005011 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-10

On-Brand Devices [LINX]

• 00855106005189: LXC-[17]
• 00855106005172: LXC-[16]
• 00855106005165: LXC-[15]
• 00855106005158: LXC-[14]
• 00855106005141: LXC-[13]
• 00855106005134: LXC-[12]
• 00855106005066: LS-[17]
• 00855106005059: LS-[16]
• 00855106005042: LS-[15]
• 00855106005035: LS-[14]
• 00855106005028: LS-[13]
• 00855106005011: LS-[12]
• 00855106005219: LINX Esophagus Sizing Tools