Endo Foam Refill - Yellow

Basic Information

• Brand Name: Endo Foam Refill - Yellow
• Primary DI: D24833630Y1
• Version / Model: 33630Y
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2023-08-30
• Public Version: 1
• Public Version Date: 2023-09-07
• Public Version Status: New
• Public Device Record Key: 5aa2fdad-ed3e-4851-be86-afb77883348a

Device Description

Endo ring foam refills

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
EIL	GAUGE, DEPTH, INSTRUMENT, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64813	Endodontic instrument chairside holder set	A collection of devices intended to be used chairside during a endodontic procedure to facilitate the access, handling, temporary storage and convenient selection of endodontic instruments (e.g., files/rasps). The set may be positioned on a surface or worn by the operator (e.g., ring design) and typically includes a plastic housing/rack, disposable spongy foam inserts for holding delicate and sharp rotary endpieces, holders for fluid containers, colour-coded identification labels/tags, and a ruler to help select an appropriate size instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D24833630Y0	HIBCC
Primary	D24833630Y1	HIBCC

Customer Contacts

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