DENTEK ON THE GO 4CT FLOSS PICK DS 36

Basic Information

• Brand Name: DENTEK ON THE GO 4CT FLOSS PICK DS 36
• Primary DI: 00047701003466
• Version / Model: 60047701003468
• Company Name: DenTek Oral Care, Inc.
• Labeler DUNS: 153818646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2022-10-21
• Public Version: 3
• Public Version Date: 2023-11-29
• Public Version Status: Update
• Public Device Record Key: be388b38-f7dc-47b3-84c0-67ecf8497fa9

Device Description

DENTEK ON THE GO 4CT FLOSS PICK DS 36

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
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	60047701003468	GS1	Multiple	4	In Commercial Distribution
Primary	00047701003466	GS1
Unit of Use	30047701003467	GS1

Customer Contacts

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