Hana/ProFx Femoral Hook Support

Basic Information

• Brand Name: Hana/ProFx Femoral Hook Support
• Primary DI: 00842430106804
• Version / Model: 6850-110
• Catalog Number: 6850-110
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-18
• Public Version: 1
• Public Version Date: 2019-02-18
• Public Version Status: New
• Public Device Record Key: f107cc50-a65f-456c-b686-a089b76bcdfb

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62665	Femur lifter, manual	A manually-operated, multi-jointed, mechanical device intended to support and elevate a patient¿s femur for optimal positioning during hip replacement surgery. It is designed to be fixed to an operating table and includes a vertical lifting post, a handcrank for height adjustment, mounting clamps/adaptors, and leg support components. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430106804	GS1

Customer Contacts

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