GUM®

Basic Information

• Brand Name: GUM®
• Primary DI: 00070942003650
• Version / Model: 230
• Catalog Number: RQ
• 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: 3
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: 59464779-2e31-43e3-aad8-12b71cfac74c

Device Description

CRAYOLA TWISTABLES TOOTHBRUSH SOFT

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: 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
31817	Basic manual toothbrush	An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device 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	10070942003657	GS1	Bag	4	In Commercial Distribution
Primary	00070942003650	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	124.5	Millimeter
Width	31	Millimeter
Depth	26	Millimeter