Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040179632
• Version / Model: 1461802
• Catalog Number: 1461802
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2024-02-23
• Public Version: 1
• Public Version Date: 2024-03-04
• Public Version Status: New
• Public Device Record Key: 45a8cfe9-61c1-4e52-994b-8f5b831adb80

Device Description

Essentials Lght Handle Barrier

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRU	CHAIR, DENTAL, WITHOUT OPERATIVE UNIT	Dental	872.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44977	Medical equipment handle cover, single-use	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. 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	00304040179635	GS1
Primary	10304040179632	GS1