Gigli Saw Handle

Basic Information

• Brand Name: Gigli Saw Handle
• Primary DI: G25007066060
• Version / Model: 07-066-06
• Catalog Number: 07-066-06
• Company Name: N S SURGICAL COMPANY
• Labeler DUNS: 645681649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-27
• Public Version: 1
• Public Version Date: 2023-05-05
• Public Version Status: New
• Public Device Record Key: 4f875d42-2e3b-4512-abe5-4db6a2792e75

Device Description

A hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is commonly known as a Gigli saw. This is a reusable device.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide, Moist Heat or Steam Sterilization, Ultraviolet Light

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
44987	Manual surgical saw, flexible	A hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is 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	G25007066060	HIBCC

Device Sizes

Type	Value	Unit	Text
Length	9	Centimeter