triFX

Basic Information

• Brand Name: triFX
• Primary DI: 17290016586500
• Version / Model: GEN 36L
• Company Name: POLLOGEN LTD
• Labeler DUNS: 514905681
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-05-30
• Public Version: 2
• Public Version Date: 2022-11-11
• Public Version Status: Update
• Public Device Record Key: ab670259-5ea7-49b6-ad62-359f94e6188a

Device Description

triFX 36L TIP ASSY 5 PACK (old name: GEN 36L DISPOSABLE TIP ASSY 5 PACKED BK)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45048	Radio-frequency skin contouring system applicator tip	A removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07290016586503	GS1
Primary	17290016586500	GS1

Premarket Submissions

Submission Number	Supplement Number
K173503	000