Insurgical, Inc.

Basic Information

• Brand Name: Insurgical, Inc.
• Primary DI: 00860007230066
• Version / Model: 320-0070-001
• Catalog Number: 9250022
• Company Name: Insurgical, Inc.
• Labeler DUNS: 078491571
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-17
• Public Version: 1
• Public Version Date: 2025-01-27
• Public Version Status: New
• Public Device Record Key: cad2d8ce-10f9-4dbb-a7da-1daaaf056ca1

Device Description

2.0 - 3.2 Pin Driver Assembly

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: 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
GFC	Driver, Surgical, Pin	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43660	Pin-driving power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a wire driving/insertion function when an appropriate orthopaedic pin is inserted (e.g., K-Wire). It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. The device may be of the micro or macro design. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007230066	GS1