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Fentex

FDA UDI

Class I (US FDA UDI)

by FENTEX medical GmbH

Identity

Trade Name
FENTEX FDA UDI
Generic Name
ENT probe, reusable FDA UDI
Device Name
Needle by Wullstein straight, blunt, color ring orange 16 cm FDA UDI
Model / Reference
154200FX8 FDA UDI
Description
Needle by Wullstein straight, blunt, color ring orange 16 cm FDA UDI

Identifiers

Catalog Number
154200FX8 FDA UDI
Primary DI / UDI-DI
04250407782146 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
ENT probe, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: ENT probe, reusable

Fentex by FENTEX medical GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FENTEX medical GmbH

Sources (1)

  • FDA UDI 0734af5a-be51-4423-befc-3b1d7b861d7d 35 fields · synced May 31, 2026