Mixer

Basic Information

• Brand Name: Mixer
• Primary DI: 04250203940917
• Version / Model: US9610
• Company Name: Joline GmbH & Co. KG
• Labeler DUNS: 342087108
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-14
• Public Version: 1
• Public Version Date: 2020-08-24
• Public Version Status: New
• Public Device Record Key: 919df560-6eaf-40aa-bf43-697a8e58b191

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: 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
61468	Manual orthopaedic cement mixer, single-use	A sterile hand-operated device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically consists of a vessel with attached/attachable mixing blades where the cement is mixed. It may include a plunger unit used to transfer the mixed cement from the vessel into an applicator prior to the surgical procedure, and a suction tube to enable connection to a separate fume extraction device. It is typically operated outside of the sterile surgical field and is not intended to contact the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250203940917	GS1