Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 00304040058084
• Version / Model: 1126736
• Catalog Number: 1126736
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-26
• Public Version: 1
• Public Version Date: 2019-12-04
• Public Version Status: New
• Public Device Record Key: 06635eb1-e411-4cf3-9799-d2db587d8d3f

Device Description

Alginate Mixer

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: Yes
• Has Lot/Batch Number: No
• 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
JDZ	MIXER, CEMENT, FOR CLINICAL USE	Orthopedic	888.4210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33191	Manual orthopaedic cement mixer, reusable	A hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304040058084	GS1