VariTrax Instrument Kit

Basic Information

• Brand Name: VariTrax Instrument Kit
• Primary DI: 00850049938082
• Version / Model: CFIK-INST
• Company Name: CircumFix Solutions, Inc.
• Labeler DUNS: 057130264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-01
• Public Version: 4
• Public Version Date: 2025-07-03
• Public Version Status: Update
• Public Device Record Key: 7b331734-edad-4b4e-895a-17d4b2b9e8be

Device Description

VariTrax Instrument Kit

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58949	General-purpose surgical scissors, single-use	A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850049938082	GS1