EdgeFind™

Basic Information

• Brand Name: EdgeFind™
• Primary DI: 00819514022367
• Version / Model: EFNDP131
• Catalog Number: EFNDP131
• Company Name: US ENDODONTICS, LLC
• Labeler DUNS: 061317427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• 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: 28ab035b-5049-4e6b-b391-3203baf24fd1

Device Description

EdgeFind™ P1 6 pack; 31

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: 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
EKS	FILE, PULP CANAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63500	Paediatric urine collection nappy	A non-sterile disposable undergarment (nappy or diaper) intended to be worn by an infant, at home or healthcare facility, to collect a paediatric urine specimen for subsequent laboratory analysis or home-testing. It resembles a conventional nappy and contains a urine accumulator which can be detached and used for the urine analysis. 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	10819514022364	GS1
Primary	00819514022367	GS1

Customer Contacts

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