Streamline MIS Spinal Fixation System

Basic Information

• Brand Name: Streamline MIS Spinal Fixation System
• Primary DI: 00191083017310
• Version / Model: 724-416
• Catalog Number: 724-416
• Company Name: Rti Surgical, Inc.
• Labeler DUNS: 117560455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 5
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 2d29f32b-9cfe-4b8e-8a70-57babd397b5f

Device Description

GENERAL SPINE CANNULATED FASCIA CHISEL

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: 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
FZO	CHISEL, SURGICAL, MANUAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34938	Orthopaedic chisel blade	A device that is an interchangeable component of an orthopaedic chisel and functions as the cutting blade which is attached and locked to a dedicated handle. Together, they become a single-blade surgical instrument, bevelled on one side, intended to cut or contour bone. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design and is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00191083017310	GS1

Customer Contacts

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