ZAVATION

Basic Information

• Brand Name: ZAVATION
• Primary DI: 08033860028022
• Version / Model: CEMENT MIXING SYSTEM
• Catalog Number: VCF-1051
• Company Name: BIOPSYBELL SRL
• Labeler DUNS: 438746708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-26
• Public Version: 3
• Public Version Date: 2018-06-13
• Public Version Status: Update
• Public Device Record Key: 54538d29-d9da-4fca-a470-50a95efab867

Device Description

VERTEBROPLASTY/KYPHOPLASTY MIXING CEMENT SYSTEM

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: Yes
• 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	08033860028022	GS1
Package	08033860028039	GS1	POUCH	10	Not in Commercial Distribution	2018-02-26

Customer Contacts

• Phone: [phone]
• Email: [email protected]