Fentex
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Surgical irrigation/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- Suction Tube straight, Luer-Lock, malleable WL 10 cm, Ø 2.5 mm FDA UDI
- Model / Reference
- 166325FX EUDAMEDFDA UDIInstrument zum Anschluss an ein Saug- / Spülgerät zur Absaugung von Flüssigkeiten und zur Spülung des Operationsfeldes. EUDAMED
- Description
- Suction Tube straight, Luer-Lock, malleable WL 10 cm, Ø 2.5 mm FDA UDI
Identifiers
- Catalog Number
- 166325FX FDA UDI
- Primary DI / UDI-DI
- 04250407717476 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504077200JV EUDAMED
- Direct Marketing DI
- 04250407717476 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- L030101 SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Surgical irrigation/aspiration cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical irrigation/aspiration cannula, non-illuminating, reusable
Fentex by FENTEX medical GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration cannula, non-illuminating, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Laryngeal cannula — Spiggle & Theis Medizintechnik GmbH · Class I
- Cannula, Suction, acc. Anthony 27.0cm long Ø4mm Charr./Fr. 12 with cone — Geister Medizin Technik GmbH · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Verhoeven suction tube — Spiggle & Theis Medizintechnik GmbH · Class I
- Modulap — ATC TECHNOLOGIES INC. · Class II
- CANNULA — SONTEC INSTRUMENTS, INC. · Class I
- Cannula, Suction, acc. Braun-Ralph spare part suction tip — Geister Medizin Technik GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 19e1c81a-da52-4184-ba5c-9d1e43cd8cf0 35 fields · synced Oct 7, 2026
- EUDAMED aae22ab1-0f36-4de2-93ed-faffa94ab77b 61 fields · synced Oct 7, 2026