GUM®

Basic Information

• Brand Name: GUM®
• Primary DI: 00070942098403
• Version / Model: 840
• Catalog Number: RQA
• Company Name: SUNSTAR AMERICAS, INC.
• Labeler DUNS: 025066358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 1
• Public Version Date: 2022-11-18
• Public Version Status: New
• Public Device Record Key: 42f292b4-a93f-4288-8750-e9ea641682f3

Device Description

EEZ-THRU FLOSS THREADERS

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: 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
JES	FLOSS, DENTAL	Dental	872.6390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11158	Dental floss	A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10070942098400	GS1	Bag	150	In Commercial Distribution
Primary	00070942098403	GS1
Unit of Use	80070942098409	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	95.25	Millimeter