OPTIVAC FUSION

Basic Information

• Brand Name: OPTIVAC FUSION
• Primary DI: 00880304488380
• Version / Model: 419000
• Catalog Number: 419000
• Company Name: BIOMET
• Labeler DUNS: 260930126
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f33cfad2-67ea-4b2f-b64a-3dacbb12e2d5

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
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	00880304488380	GS1

Customer Contacts

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