Hybrid Energy (HE) disposable tips

Basic Information

• Brand Name: Hybrid Energy (HE) disposable tips
• Primary DI: 07290016586053
• Version / Model: gen36
• Catalog Number: 30010090
• Company Name: POLLOGEN LTD
• Labeler DUNS: 514905681
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-04-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8b99569e-6c16-43de-93ac-679e1866e2b2

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: Yes
• 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
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
Primary	07290016586053	GS1
Unit of Use	17290016586050	GS1