Identity
- Trade Name
- TRACHEOBRONXANE™ DUMON™ RADIO OPAQUE FDA UDI
- Generic Name
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
- Device Name
- BO 11 L 40 FDA UDI
- Model / Reference
- 04961R FDA UDI
- Description
- BO 11 L 40 FDA UDI
Identifiers
- Catalog Number
- 04961R FDA UDI
- Primary DI / UDI-DI
- EBES04961R0 FDA UDI
- 510(k) Number
- K971509 FDA UDI
- FDA Product Code
- NWA FDA UDI
- GMDN Term
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Polymeric tracheal/bronchial stent, non-bioabsorbable
Tracheobronxane™ Dumon™ Radio Opaque by Novatech — Class II — FDA UDI — listed in FDA GUDID — 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
K971509 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 (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 II | Pending data |
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Manufacturer
- Manufacturer
- Novatech
Sources (1)
- FDA UDI 58026343-80b5-43aa-92c7-5400d30e2ad7 37 fields · synced May 31, 2026