FENIX

Basic Information

• Brand Name: FENIX
• Primary DI: 00855106005486
• Version / Model: FXS-[15]
• Company Name: Torax Medical, Inc.
• Labeler DUNS: 137949538
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5884aa43-ce77-4e98-a964-1a0ccd1d8ac2
• Distribution End Date: 2017-11-13

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMH	Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
34092	Anal sphincter prosthesis	A sterile device that functions as an artificial substitute for an anal sphincter intended to treat severe faecal incontinence (loss of control of the bowel). It is typically a fluid-filled implantable device made of silicone elastomer and consisting of tubing-connected components, including an occlusive cuff that fits around the anal canal, a pressure-regulating balloon, and a control pump. The patient regulates bowel evacuation by manually pumping fluid from the cuff to the balloon. This device is typically used in patients who have failed, or are not candidates for, less invasive forms of restorative therapy.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855106005486	GS1

Premarket Submissions

Submission Number	Supplement Number
H130006	000