QuadVantage

Basic Information

• Brand Name: QuadVantage
• Primary DI: 00850050146087
• Version / Model: 41004
• Catalog Number: 41004
• Company Name: Quadvantage Technology, Inc.
• Labeler DUNS: 112134851
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-19
• Public Version: 1
• Public Version Date: 2023-06-27
• Public Version Status: New
• Public Device Record Key: d88d80fe-d184-4703-b288-4485287378b8

Device Description

QuadVantage 9mm Disposable Blade Set. One blade Kit is used per surgery/ case and then disposed of. Blades included are intended to be used with the QuadVanatage Cobra Harvester (UDI 00850050146063) and the QuadSabre (UDI 00850050146056)

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: No
• 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
HTS	Knife, Orthopedic	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850050146087	GS1

Customer Contacts

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