Gen2

Basic Information

• Brand Name: Gen2
• Primary DI: 00840343719418
• Version / Model: G2G1431
• Catalog Number: G2G1431
• Company Name: SURGIX MEDICAL LLC
• Labeler DUNS: 080402644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-08
• Public Version: 1
• Public Version Date: 2023-11-16
• Public Version Status: New
• Public Device Record Key: 3aea9c82-38fe-448a-9737-8fee96d41b0b

Device Description

KNIFE HANDLE ROUND, BEAVER HANDLE BLUNT BLUNT

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
GDZ	Handle, Scalpel	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12235	Scalpel handle, reusable	A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840343719418	GS1

Customer Contacts

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