Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040089924
• Version / Model: 9007989
• Catalog Number: 9007989
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-05-29
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: dbae2f3b-a8cf-467a-b8cf-2a3f9ebadb48

Device Description

Sectional Matrix Tip Refill

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: 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
EKF	INSTRUMENT, CONTOURING, MATRIX, OPERATIVE	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16370	Dental wedge, reusable	A small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10304040089924	GS1
Unit of Use	00304040089927	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: To be stored in dry and fresh place, protected from sunlight