GEN2

Basic Information

• Brand Name: GEN2
• Primary DI: 00840343702182
• Version / Model: G2N49415
• Catalog Number: G2N49415
• Company Name: SURGIX MEDICAL LLC
• Labeler DUNS: 080402644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-20
• Public Version: 1
• Public Version Date: 2022-10-28
• Public Version Status: New
• Public Device Record Key: b4ac7da4-ef15-44be-9678-73cff05b0c33

Device Description

HARDY TRANSSPHENOIDAL KNIFE HANDLE VERTICAL

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
GZX	Instrument, Microsurgical	Neurology	882.4525	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	00840343702182	GS1
Previous	G277G2N494150	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	9.75	Inch