EdgePack™

Basic Information

• Brand Name: EdgePack™
• Primary DI: 00818365028375
• Version / Model: EEDPUT4004
• Catalog Number: EEDPUT4004
• Company Name: US ENDODONTICS, LLC
• Labeler DUNS: 061317427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: 37014f97-7388-4805-ac2f-677c4fb9fda3

Device Description

EdgePack WP4004 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: 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
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	00818365028375	GS1

Customer Contacts

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