FENTEX

Basic Information

• Brand Name: FENTEX
• Primary DI: 04250407778408
• Version / Model: 270030FX
• Catalog Number: 270030FX
• Company Name: FENTEX medical GmbH
• Labeler DUNS: 507221724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-09
• Public Version: 1
• Public Version Date: 2022-12-19
• Public Version Status: New
• Public Device Record Key: 021e909c-0edf-47a5-9f49-10e9889c43e6

Device Description

Handle without suction control

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
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64240	Ear canal suction handle	A noninvasive, non-powered, hand-held device intended to be connected to, and facilitate manipulation of, an appropriate cannula (not included) for suction/removal (aspiration) of debris from the ear canal during an ear/nose/throat (ENT) procedure; it is not intended for irrigation. It is in the form of a cylinder with an inner lumen which may incorporate a side-hole for low-level suction control (e.g., using the thumb); it does not incorporate a switch(es), valve(s) or button(s). It may include connection tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250407778408	GS1

Customer Contacts

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