EdgeV-File HT™

Basic Information

• Brand Name: EdgeV-File HT™
• Primary DI: 00818365027804
• Version / Model: EVHTPP3506
• Catalog Number: EVHTPP3506
• Company Name: US ENDODONTICS, LLC
• Labeler DUNS: 061317427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-06-25
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: b109546f-afef-4857-8c43-fbf29f444152

Device Description

EdgeV-File HT™ Paper Points 35.06

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: 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	10818365027801	GS1
Primary	00818365027804	GS1

Customer Contacts

• Phone: [phone] ext. 103
• Email: [email protected]