TS1 Tongue Vacuum Cleaner

Basic Information

• Brand Name: TS1 Tongue Vacuum Cleaner
• Primary DI: D2486300621
• Version / Model: 630062
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-08-20
• Public Version: 1
• Public Version Date: 2024-08-28
• Public Version Status: New
• Public Device Record Key: 5afe0f18-00f8-4140-abf4-e11e7f8f1c6c

Device Description

Tongue scraper

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
LCN	SCRAPER, TONGUE	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16308	Tongue scraper, single-use	A non-sterile device designed to scrape the upper surface of the tongue to promote oral hygiene (e.g., to remove plaque, food debris, and bacteria, and to prevent bad breath). It is normally available [non-prescription] over-the-counter (OTC). It is typically made of plastic and is available in a variety of designs (e.g., a U-shaped band or a T-shaped instrument), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D2486300620	HIBCC
Primary	D2486300621	HIBCC