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Tracheobronxane™ Dumon™ Radio Opaque

FDA UDI

Class II (US FDA UDI)

by Novatech

Identity

Trade Name
TRACHEOBRONXANE™ DUMON™ RADIO OPAQUE FDA UDI
Generic Name
Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
Device Name
Y 16-13-13 L 110-50-50 FDA UDI
Model / Reference
093011R FDA UDI
Description
Y 16-13-13 L 110-50-50 FDA UDI

Identifiers

Catalog Number
093011R FDA UDI
Primary DI / UDI-DI
EBES093011R0 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
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Tracheobronxane™ Dumon™ Radio Opaque by Novatech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K971509 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novatech

Sources (1)

  • FDA UDI 34762092-b625-456b-8093-5463834429ff 38 fields · synced Jun 1, 2026