Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040168902
• Version / Model: 2020643
• Catalog Number: 2020643
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-03-17
• Public Version: 1
• Public Version Date: 2023-03-27
• Public Version Status: New
• Public Device Record Key: ae4df89e-236e-4762-b1ec-f91ed3b63adc

Device Description

CHANNELS Handpiece Silicon Covers

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKX	Handpiece, direct drive, ac-powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66245	Dental surgical power tool motorized handpiece/set, electric	An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. 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	00304040168905	GS1
Primary	10304040168902	GS1

Premarket Submissions

Submission Number	Supplement Number
K203320	000