Fentex

FDA UDI

Class I (US FDA UDI)

by FENTEX medical GmbH

Identity

Trade Name: FENTEX FDA UDI
Generic Name: Nasal knife FDA UDI
Device Name: Round Knife by Draf bayonet-shaped, vertical cutting 19 cm FDA UDI
Model / Reference: 239502FX FDA UDI
Description: Round Knife by Draf bayonet-shaped, vertical cutting 19 cm FDA UDI

Identifiers

Catalog Number: 239502FX FDA UDI
Primary DI / UDI-DI: 04250407725273 FDA UDI
FDA Product Code: LRC FDA UDI
GMDN Term: Nasal knife FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Nasal knife

FENTEX is a high-grade stainless steel hand-held manual surgical instrument designed for ear, nose, and throat (ENT) surgery. This one-piece instrument features a unique cutting blade made of various forms, including sharply-pointed, double-edged, or swivel devices, tailored to specific procedures. With its sterilization methods available as Moist Heat or Steam Sterilization, FENTEX ensures effective infection control during surgical operations.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: FENTEX medical GmbH

Sources (1)

FDA UDI 8a23a0de-150e-435a-89a1-b13723229b49 35 fields · synced Jul 24, 2026