KIWI Derma

Basic Information

• Brand Name: KIWI Derma
• Primary DI: 07350120791955
• Version / Model: Lavender
• Company Name: Foreo AB
• Labeler DUNS: 352394143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-11
• Public Version: 1
• Public Version Date: 2024-03-19
• Public Version Status: New
• Public Device Record Key: f9d3fd48-43de-4c48-98d0-476b5212bba7

Device Description

KIWI Derma is blackhead suction device with microdermabrasion nozzle to remove dead skin and with T-sonic pulsation to suck out blackhead more easily.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
KNM	Device, Pressure Applying	Physical Medicine	890.5765	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32388	Dermabrasion brush, rotary	A device with wire bristles that is rotated in a power-driven tool to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350120791955	GS1