Novo Surgical

Basic Information

• Brand Name: Novo Surgical
• Primary DI: G586N96875710
• Version / Model: N96875-71
• Catalog Number: N96875-71
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-18
• Public Version: 1
• Public Version Date: 2023-12-26
• Public Version Status: New
• Public Device Record Key: 7a582fb8-e78f-430a-8fbc-445af632b70f

Device Description

zenith gigli (olivecrona) wire saw, standard, twisted wire type, 23-3/4" (60.0 cm)

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: 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
GDR	SAW, MANUAL AND ACCESSORIES	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44982	Manual surgical saw blade, flexible, reusable	A flexible, wire-like, metal surgical instrument, usually of a high-grade stainless steel, typically intended to be used in orthopaedic or neurological surgery to cut bone. It has a serrated surface, or a surface coated with an abrasive material, and functions as the cutting blade of a flexible manual hand saw commonly known as a Gigli saw. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G586N96875710	HIBCC

Customer Contacts

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