Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040131487
• Version / Model: 009007489
• Catalog Number: 9007489
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-03-27
• Public Version: 1
• Public Version Date: 2020-04-06
• Public Version Status: New
• Public Device Record Key: 3ce02ec4-d3f9-4eab-8592-a8d72466b29a

Device Description

Clear Fiber Post Serrated

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELR	POST, ROOT CANAL	Dental	872.3810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45650	Root canal post kit	A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. 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	00304040131480	GS1
Primary	10304040131487	GS1