THERMAGE FLX

Basic Information

• Brand Name: THERMAGE FLX
• Primary DI: 00816995021285
• Version / Model: TR-4
• Catalog Number: TR-4
• Company Name: SOLTA MEDICAL
• Labeler DUNS: 079999584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-08
• Public Version: 4
• Public Version Date: 2018-11-05
• Public Version Status: Update
• Public Device Record Key: 2d69dcca-0325-482c-aaa1-227e50c1bbee

Device Description

THERMAGE FLX PATIENT RETURN PAD

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45049	Radio-frequency skin contouring system electrode, return	A non-active conductor that is part of a skin contouring system that uses radio-frequency (RF) energy and that is placed on a patient's skin to provide a complete electrical circuit for energy transferred to the patient from a monopolar applicator. This device is affixed to the patient's body typically where the greatest surface area is utilized during treatment and helps to prevent the occurrence of electrical burns. It may have a mat-like design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816995021285	GS1