EDGE ENDO

Basic Information

• Brand Name: EDGE ENDO
• Primary DI: 00810988031411
• Version / Model: EEDPUT4004
• Catalog Number: EEDPUT4004
• Company Name: HANDPIECE PARTS & REPAIRS, INC.
• Labeler DUNS: 079723355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-20
• Public Version: 1
• Public Version Date: 2023-04-28
• Public Version Status: New
• Public Device Record Key: 089a1d7e-e89a-4130-b50a-a3c8034b861a

Device Description

EdgePack 4004 Tip

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKR	Plugger, Root Canal, Endodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45249	Endodontic obturation system handpiece, heat conducting	A handpiece, which is part of an endodontic obturation system, intended to control through its hand-switch an electrical current from the generator to the tip of an attached dental instrument where it is converted to resistive heat used to test tooth response to thermal stimulus during treatment involving root canal obturation procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810988031411	GS1