← Back to catalogue

Fentex

FDA UDI

Class I (US FDA UDI)

by FENTEX medical GmbH

Identity

Trade Name
FENTEX FDA UDI
Generic Name
Middle ear chisel FDA UDI
Device Name
Chisel by Trautmann (Partsch) 14 cm, width 4 mm FDA UDI
Model / Reference
120204FX FDA UDI
Description
Chisel by Trautmann (Partsch) 14 cm, width 4 mm FDA UDI

Identifiers

Catalog Number
120204FX FDA UDI
Primary DI / UDI-DI
04250407712563 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Middle ear chisel FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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: Middle ear chisel

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

Similar devices

Also classified as Middle ear chisel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
FENTEX medical GmbH

Sources (1)

  • FDA UDI 6bdbd263-ff42-4219-b300-94d2a1e81619 35 fields · synced Jun 1, 2026