GUM®

Basic Information

• Brand Name: GUM®
• Primary DI: 00070942005395
• Version / Model: 4110
• Catalog Number: URB
• Company Name: SUNSTAR AMERICAS, INC.
• Labeler DUNS: 025066358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-06-14
• Public Version: 3
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 5d055a3c-bec2-456f-895c-6a360a453b33

Device Description

Sonic Deep Clean Refills, Black, 2-pack

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: No
• 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
JES	FLOSS, DENTAL	Dental	872.6390	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
Package	10070942005392	GS1	Box	4	In Commercial Distribution
Primary	00070942005395	GS1
Unit of Use	80070942005391	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	75.8	Millimeter