FENTEX

Basic Information

• Brand Name: FENTEX
• Primary DI: 04250407738334
• Version / Model: 469110FX
• Catalog Number: 469110FX
• 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: f81aa322-f690-403e-b9bb-4c855768077b

Device Description

Tracheal Trocar by Denker (Uckermann) 13 cm, Ø 9 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: 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
45919	Tracheal trocar blade	A hand-held manual surgical instrument with a sharp pyramidal or conical point designed to puncture the trachea during tracheotomy. It is typically assembled and used with a compatible tube (not included), e.g., a tube identical to that of a tracheostomy tube, filling its lumen, thereby allowing the introduction of this assembly. Following puncture, the trocar is withdrawn providing a stoma through which the patient can breathe. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250407738334	GS1

Customer Contacts

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