Tenex Health TX®

Basic Information

• Brand Name: Tenex Health TX®
• Primary DI: 00857156006291
• Version / Model: 554-0001-001
• Catalog Number: 554-0001-001
• Company Name: TENEX HEALTH, INC.
• Labeler DUNS: 038720788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-15
• Public Version: 1
• Public Version Date: 2020-07-23
• Public Version Status: New
• Public Device Record Key: bfb6d7e3-deed-4178-be91-505e8db05db5

Device Description

TX Foot Pedal

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, Ultrasonic Surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
37776	Ultrasonic suction system	An assembly of mains electricity (AC-powered) devices designed to use mechanical ultrasonic vibration and a combination of irrigation and suction to fragment and remove soft tissue and growths of high water content from various parts of the body. Ultrasonic suction units are used during neurosurgery, general surgery, and gynaecological and orthopaedic procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857156006291	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123640	000
K153299	000
K181367	000