KYPHON ELEMENT™ Balloon Kyphoplasty System

Basic Information

• Brand Name: KYPHON ELEMENT™ Balloon Kyphoplasty System
• Primary DI: 00643169582248
• Version / Model: F25R
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-08
• Public Version: 1
• Public Version Date: 2019-03-18
• Public Version Status: New
• Public Device Record Key: 8eea7328-aab1-4e98-ac2c-5855c6c1e2ec

Device Description

BONE FILLER DEVICE F25R 3 VALUE BFD

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIH	DISPENSER, CEMENT	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35809	Orthopaedic cement dispenser	A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169582248	GS1

Customer Contacts

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