Fentex

FDA UDI

Class I (US FDA UDI)

by FENTEX medical GmbH

Identity

Trade Name: FENTEX FDA UDI
Generic Name: Metal/carbide ENT bur, reusable FDA UDI
Device Name: Hand-Burr Stainless Steel, straight 16.5 cm, Ø 0.6 mm FDA UDI
Model / Reference: 162807FX FDA UDI
Description: Hand-Burr Stainless Steel, straight 16.5 cm, Ø 0.6 mm FDA UDI

Identifiers

Catalog Number: 162807FX FDA UDI
Primary DI / UDI-DI: 04250407780784 FDA UDI
FDA Product Code: LRC FDA UDI
GMDN Term: Metal/carbide ENT bur, 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

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: Metal/carbide ENT bur, reusable

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

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Bur PM2-70 50K Carb Ø0.5 — Bien-Air Surgery SA · Class I
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GYRUS ACMI — Gyrus Acmi, Inc. · Class I
GYRUS ACMI — Gyrus Acmi, Inc. · Class I

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 abbec12a-f26b-4fb0-b60d-2c9c680bd78e 35 fields · synced May 30, 2026