Fentex

FDA UDI

Class I (US FDA UDI)

by FENTEX medical GmbH

Identity

Trade Name: FENTEX FDA UDI
Generic Name: Surgical tissue compression device FDA UDI
Device Name: Bone & Cartilage Crusher by Tolsdorff to press pieces of bone up to Ø 4 mm FDA UDI
Model / Reference: 350700FX FDA UDI
Description: Bone & Cartilage Crusher by Tolsdorff to press pieces of bone up to Ø 4 mm FDA UDI

Identifiers

Catalog Number: 350700FX FDA UDI
Primary DI / UDI-DI: 04250407730826 FDA UDI
FDA Product Code: LRC FDA UDI
GMDN Term: Surgical tissue compression device 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: Surgical tissue compression device

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

Similar devices

Also classified as Surgical tissue compression device.

Arthrex® — Arthrex, Inc. · Class I
BR Surgical, LLC — BR SURGICAL LLC · Class I
GUBISCH CARTILAGE CRUSHER — SONTEC INSTRUMENTS, INC. · Class I
V. Mueller — STERIS CORPORATION · Class I
Symmetry Cottle — SYMMETRY SURGICAL INC. · Class I
Trigon — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
EVONOS — Gyrus Acmi, Inc. · Class I
BOSS Instruments — Boss Instruments, Ltd. · 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 b33f6121-579f-4ab6-ab8f-4baa8b3064dd 35 fields · synced Jun 8, 2026