Top Quality Manufacturing

Basic Information

• Brand Name: Top Quality Manufacturing
• Primary DI: TQ26SE2555121
• Version / Model: SE2-5551
• Company Name: TOP QUALITY MANUFACTURING, INC.
• Labeler DUNS: 113630649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2024-10-31
• Public Version: 1
• Public Version Date: 2024-11-08
• Public Version Status: New
• Public Device Record Key: 65e1fe32-12ac-4b77-9606-065b3aa32dfd

Device Description

TQMPL Saliva Ejectors - Clear / Blue Tip

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
Unit of Use	TQ26SE2555120	HIBCC
Primary	TQ26SE2555121	HIBCC

Customer Contacts

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