Optivac Total Hip Kit

Basic Information

• Brand Name: Optivac Total Hip Kit
• Primary DI: 00880304370562
• Version / Model: 417000
• Catalog Number: 417000
• 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: 3
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: d55de622-5c0e-4cbe-bf2f-94c7d1530e3f

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
44742	Joint prosthesis implantation kit, reusable	A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304370562	GS1

Customer Contacts

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