Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040054823
• Version / Model: 1002868
• Catalog Number: 1002868
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 2
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: be67563d-580f-48dd-9edb-61a46f0a3df6

Device Description

Polycarbonate Crowns

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: No
• PM Exempt: Yes
• 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
ELZ	CROWN, PREFORMED	Dental	872.3330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34976	Preformed dental crown, temporary	A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00304040054826	GS1
Primary	10304040054823	GS1