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Fentex
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 120108FXModel Instrument zum Durchtrennen, Einbringen oder Verdichten.
Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Surgical gouge FDA UDI
- Device Name
- Gouge by Trautmann (Partsch) 14 cm, width 8 mm FDA UDI
- Model / Reference
- 120108FX EUDAMEDFDA UDIInstrument zum Durchtrennen, Einbringen oder Verdichten. EUDAMED
- Description
- Gouge by Trautmann (Partsch) 14 cm, width 8 mm FDA UDI
Identifiers
- Catalog Number
- 120108FX FDA UDI
- Primary DI / UDI-DI
- 04250407712518 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250407712518 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L090403 ORTHOPAEDIC SURGERY GOUGES, REUSABLE EUDAMED
- GMDN Term
- Surgical gouge FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical gouge
Fentex by FENTEX medical GmbH — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FENTEX medical GmbH
Sources (2)
- FDA UDI 1495d7ce-515d-4986-947b-7727be445170 35 fields · synced Oct 7, 2026
- EUDAMED 3ac57325-ee1d-4b93-903e-514fde692f59 61 fields · synced Oct 7, 2026