Gen2

Basic Information

• Brand Name: Gen2
• Primary DI: 00840343700348
• Version / Model: G2E17055
• Catalog Number: G2E17055
• Company Name: SURGIX MEDICAL LLC
• Labeler DUNS: 080402644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-18
• Public Version: 1
• Public Version Date: 2022-10-26
• Public Version Status: New
• Public Device Record Key: 239ac1e1-d486-49dc-ab8d-e1bd9b9e2d26

Device Description

HOUSE SUCTION IRRIGATOR 4x5 FR

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
JZF	Tube, Ear Suction	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36269	Surgical irrigation/aspiration cannula, illuminating, reusable	An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It has a built-in light or fibreoptic bundle for illumination. The device may incorporate a handle with side valve(s)/hole(s) for the control of irrigation/aspiration, and may be provided with a stylet, sheath, and/or connection tubing. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840343700348	GS1
Previous	G277G2E170550	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Gauge 4 French Gauge (FR)
Device Size Text, specify			Gauge 5 French Gauge (FR)
Device Size Text, specify			Length size 5.5 inches