FENTEX

Basic Information

• Brand Name: FENTEX
• Primary DI: 04250407749033
• Version / Model: 711403FX
• Catalog Number: 711403FX
• Company Name: FENTEX medical GmbH
• Labeler DUNS: 507221724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: c63297a5-f0f4-44bb-a045-3b43238b9881

Device Description

Heine Adapter connection light source

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
EQH	SOURCE, CARRIER, FIBEROPTIC LIGHT	Ear, Nose, Throat	874.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46113	Endoscopic light source adaptor	A device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250407749033	GS1

Customer Contacts

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