Identity
- Trade Name
- TRACHEOBRONXANE™ DUMON® FDA UDI
- Generic Name
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
- Device Name
- TD 13 L 60 FDA UDI
- Model / Reference
- 03321 FDA UDI
- Description
- TD 13 L 60 FDA UDI
Identifiers
- Catalog Number
- 03321 FDA UDI
- Primary DI / UDI-DI
- 14063108106329 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
MR Safe FDA UDI
Category: Polymeric tracheal/bronchial stent, non-bioabsorbable
Tracheobronxane™ Dumon® 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 c81aca40-6b9e-489f-a803-e6d7e3ff05ce 37 fields · synced May 31, 2026