FENIX

GUDID 00855106005516

Torax Medical, Inc.

Anal sphincter prosthesis

• Primary Device ID: 00855106005516
• NIH Device Record Key: 1c647612-bdbf-40a9-b8e3-ee1dfd716145
• Commercial Distribution Discontinuation: 2017-11-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FENIX
• Version Model Number: FXS-[18]
• Company DUNS: 137949538
• Company Name: Torax Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00855106005516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H130006

FDA Product Code

• PMH: Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)

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: 2016-02-19

On-Brand Devices [FENIX]

• 00855106005547: FENIX Beaded Sizer
• 00855106005530: FXS-[20]
• 00855106005523: FXS-[19]
• 00855106005516: FXS-[18]
• 00855106005509: FXS-[17]
• 00855106005493: FXS-[16]
• 00855106005486: FXS-[15]
• 00855106005479: FXS-[14]
• 00855106005462: 5-pack FENIX Tape Sizer
• 00855106005448: FENIX Introducer