CosmoLock Pedicle Screw System

Basic Information

• Brand Name: CosmoLock Pedicle Screw System
• Primary DI: B07310K0191130
• Version / Model: 10-K01-9113
• Company Name: Kalitec Direct LLC
• Labeler DUNS: 041956211
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-14
• Public Version: 1
• Public Version Date: 2018-10-15
• Public Version Status: New
• Public Device Record Key: db38a9f3-ea74-432c-94b9-bb648d2618f7

Device Description

Dilator, Large

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: No
• 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
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32338	Fascial tissue dilator, reusable	A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or surgical procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose at its distal end, that is available in a variety of sizes and made of metal (e.g., stainless steel). It is typically used for the dilatation of fascial tissue around peripheral vasculature, puncture sites, and various ducts. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B07310K0191130	HIBCC