Tracheobronxane™ Dumon®
FDA UDIEUDAMEDClass II (US FDA UDI)
by Novatech
Identity
- Trade Name
- TRACHEOBRONXANE™ DUMON® FDA UDI
- Generic Name
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
- Device Name
- TRACHEOBRONXANE DUMON EUDAMEDTracheo-bronchial silicone stent, TF 13 L 60 FDA UDI
- Model / Reference
- 03321FS EUDAMEDFDA UDI
- Description
- Tracheo-bronchial silicone stent, TF 13 L 60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14063108100518 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14063108100518 EUDAMED
- 510(k) Number
- K243126 FDA UDI
- FDA Product Code
- NWA FDA UDI
- EMDN Code
- P0401 TRACHEOBRONCHIAL PROSTHESES EUDAMED
- GMDN Term
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3720 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Polymeric tracheal/bronchial stent, non-bioabsorbable
Tracheobronxane™ Dumon® by Novatech — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric tracheal/bronchial stent, non-bioabsorbable.
- AERO® — Merit Medical Systems, Inc. · Class II
- AERO® — Merit Medical Systems, Inc. · Class II
- AEROmini® — Merit Medical Systems, Inc. · Class II
- AEROmini® — Merit Medical Systems, Inc. · Class II
- AERO DV® — Merit Medical Systems, Inc. · Class II
- AERO DV® — Merit Medical Systems, Inc. · Class II
- TRACHEOBRONXANE™ DUMON® — NOVATECH · Class II
- TRACHEOBRONXANE™ DUMON® RADIOPAQUE — NOVATECH · Class II
Cleared under the same submission
K243126 also covers:
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
- TRACHEOBRONXANE™ DUMON® — NOVATECH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Novatech
Sources (2)
- FDA UDI d469ce48-4c29-4811-8655-e83007e66af7 34 fields · synced Jun 19, 2026
- EUDAMED b84e9d43-903b-474e-85eb-89f35ab71368 61 fields · synced Jun 19, 2026