Endoring Filecaddy

Basic Information

• Brand Name: Endoring Filecaddy
• Primary DI: 00859611006396
• Version / Model: EFCFY-S
• Catalog Number: EFCFY-S
• Company Name: JORDCO INC
• Labeler DUNS: 803063981
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-08
• Public Version: 1
• Public Version Date: 2020-08-17
• Public Version Status: New
• Public Device Record Key: 16fa6e50-3afc-4b04-bfdc-ed4538d225b8

Device Description

Endoring Filecaddy Foam Inserts All Yellow Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
64833	Endodontic instrument-holding insert, reusable	A device intended to be fitted into a container designed to store endodontic instruments (e.g., files/rasps), typically chairside prior to a clinical procedure or during a sterilization procedure. It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859611006396	GS1

Customer Contacts

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