GUM®

Basic Information

• Brand Name: GUM®
• Primary DI: 00070942127516
• Version / Model: 460
• Catalog Number: RQB
• Company Name: SUNSTAR AMERICAS, INC.
• Labeler DUNS: 025066358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 2
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: 7efab0dc-ebcf-45d3-b6e1-a1cb1ede6352

Device Description

SUPER TIP SOFT/REGULAR, PROXABRUSH GO-BETWEENS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: No
• 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
EFW	TOOTHBRUSH, MANUAL	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33208	Periodontal pick/brush, reusable	A manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10070942127513	GS1	Bag	6	In Commercial Distribution
Primary	00070942127516	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	69.95	Millimeter
Width	7.11	Millimeter
Depth	7.11	Millimeter
Height	190	Millimeter
Width	13.31	Millimeter
Depth	5.94	Millimeter