ISSA™ baby

Basic Information

• Brand Name: ISSA™ baby
• Primary DI: 07350092139908
• Version / Model: STRAWBERRY ROSE LION
• Company Name: Foreo AB
• Labeler DUNS: 352394143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-25
• Public Version: 1
• Public Version Date: 2022-06-02
• Public Version Status: New
• Public Device Record Key: 4398d7ac-89bb-4931-801b-992a80e38b6c

Device Description

ISSA™ baby is a high-tech sonic power toothbrush that gently removes plaque. The ISSA™ baby is intended for children 0-4 years old.

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: No
• Has Lot/Batch Number: Yes
• 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
JEQ	Toothbrush, Powered	Dental	872.6865	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43090	Basic electric toothbrush	An electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350092139908	GS1