FENTEX

Basic Information

• Brand Name: FENTEX
• Primary DI: 04250407702199
• Version / Model: 024200FX
• Catalog Number: 024200FX
• Company Name: FENTEX medical GmbH
• Labeler DUNS: 507221724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 4c7f85ce-6264-4d21-af9b-39b355cca82a

Device Description

Ear Spatula by Zaufal 16 cm

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
35346	Middle ear spatula	A hand-held manual surgical instrument designed to manipulate middle ear tissue or structures during ear/nose/throat (ENT) surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a flat blunt blade (no sharp edges) at the distal tip. Progressing from the handle to the distal tip the shaft or the blade may be straight, curved, or turn at various angles. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250407702199	GS1

Customer Contacts

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