Mixing Bowl

Basic Information

• Brand Name: Mixing Bowl
• Primary DI: 08800038055322
• Version / Model: MXB001
• Company Name: IMEDICOM CO., LTD.
• Labeler DUNS: 690340653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 2
• Public Version Date: 2023-10-20
• Public Version Status: Update
• Public Device Record Key: 97ef6802-2cb2-4f22-9fd2-a026b1dbdebc

Device Description

Bone Cement Mixing System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
36000	Orthopaedic cement mixing bowl	A sterile device designed for the specific purpose of containing the components that comprise orthopaedic bone cement while these are being mixed prior to application on a patient. It is typically used together with an orthopaedic cement mixer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800038055322	GS1