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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 transilluminator FDA UDI
Device Name
Fiber Optic Light Carrier FDA UDI
Model / Reference
540524FX FDA UDI
Description
Fiber Optic Light Carrier FDA UDI

Identifiers

Catalog Number
540524FX FDA UDI
Primary DI / UDI-DI
04250407761295 FDA UDI
FDA Product Code
KAL FDA UDI
GMDN Term
ENT transilluminator 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 transilluminator

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

Similar devices

Also classified as ENT transilluminator.

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 6b6f5910-c80b-484a-b6e3-1caff2386010 35 fields · synced May 30, 2026