Top Quality Manufacturing

Basic Information

• Brand Name: Top Quality Manufacturing
• Primary DI: TQ26180091161
• Version / Model: 18009116
• Company Name: TOP QUALITY MANUFACTURING, INC.
• Labeler DUNS: 113630649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-10-30
• Public Version: 1
• Public Version Date: 2024-11-07
• Public Version Status: New
• Public Device Record Key: b788ba72-0ea2-4ce9-bf9b-40564572ece4

Device Description

TQMPL Absorbent Paper Points - Taper .04, Size #20

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
EKN	POINT, PAPER, ENDODONTIC	Dental	872.3830	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38777	Endodontic paper point	A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. 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	TQ26180091160	HIBCC
Primary	TQ26180091161	HIBCC

Customer Contacts

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