FENTEX

Basic Information

• Brand Name: FENTEX
• Primary DI: 04250407764654
• Version / Model: 700710FX
• Catalog Number: 700710FX
• Company Name: FENTEX medical GmbH
• Labeler DUNS: 507221724
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 3
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 5c612db8-20c0-4748-8dde-273bd6c526bc
• Distribution End Date: 2022-12-31

Device Description

Nasopharyngoscope 0°, WL 300 mm, Ø 3.4 mm

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: No
• Has Serial Number: Yes
• 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
EOB	Nasopharyngoscope (flexible or rigid)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35204	Flexible fibreoptic nasopharyngoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250407764654	GS1

Customer Contacts

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