Lingua-Fix®

Basic Information

• Brand Name: Lingua-Fix®
• Primary DI: 10840161304732
• Version / Model: 50Z953S
• Company Name: ZIRC DENTAL PRODUCTS, INC.
• Labeler DUNS: 064783913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-10-04
• Public Version: 1
• Public Version Date: 2022-10-12
• Public Version Status: New
• Public Device Record Key: e3bfd687-352a-48a7-a6ef-8c24e648b577

Device Description

Lingua Fix 10pk

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
DYN	Mouthpiece, Saliva Ejector	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37434	Dental suction system cannula, single-use	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10840161304732	GS1
Unit of Use	00840161304735	GS1

Device Sizes

Type	Value	Unit	Text
Length	22.9	Centimeter
Width	15.2	Centimeter