Rampart One Lumbar Interbody Fusion System

Basic Information

• Brand Name: Rampart One Lumbar Interbody Fusion System
• Primary DI: M7404910007
• Version / Model: 49-04-01
• Catalog Number: 491-0007
• Company Name: SPINEOLOGY INC.
• Labeler DUNS: 033014361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-09
• Public Version: 1
• Public Version Date: 2024-01-17
• Public Version Status: New
• Public Device Record Key: 67a925c2-1bbb-467c-8056-82dda69983e3

Device Description

Fixed Angle Housing

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37532	Centrifuge rotor, fixed angle	A device, commonly called the rotor, or rotor head, used as a component in a centrifuge. It is designed with the tube holding bores formed at a pre-set angle and pattern. It is horizontally attached at the top of the vertical shaft which is part of the electrically-powered drive unit and the samples to be centrifuged are placed in this rotor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7404910007	HIBCC

Customer Contacts

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