FDA.reportPublic FDA data

TRACHEOBRONXANE™ DUMON®

Primary DI
14063108100310
Brand
TRACHEOBRONXANE™ DUMON®
Company
NOVATECH
Model
03581S
Device description
Tracheo-bronchial silicone stent, TD 15 L 80
Published
2024-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NWAProsthesis, Tracheal, Preformed/Molded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWAProsthesis, Tracheal, Preformed/MoldedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243126000TRACHEOBRONXANE™ DUMON®Novatech SA2024-10-29NWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14063108100310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1406310810031014063108100310

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric tracheal/bronchial stent, non-bioabsorbableA non-bioabsorbable tubular device intended to be implanted into the trachea and/or a bronchus/bronchiole to maintain luminal patency, typically used in cases of obstructions/stenoses, fistulae, tumours, scarring, surgical resection and anastomosis, or pulmonary transplantation. It is made entirely of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., semi-soft continuous tube, covered or non-covered mesh structure, straight or branched configuration) intended to conform to the endotracheal/endobronchial surface. It may be expandable in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
777211640
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14063108105162DUTAU NOVATECH02BRD SET2025-02-16
14063108105179DUTAU NOVATECH02BRD SET FR2025-02-16
14063108105186DUTAU NOVATECH02BRD11002025-02-16
14063108105209DUTAU NOVATECH02BRD1100-12025-02-16
14063108105216DUTAU NOVATECH02BRD1100-22025-02-16
14063108105223DUTAU NOVATECH02BRD11102025-02-16
14063108105230DUTAU NOVATECH02BRD11202025-02-16
14063108105247DUTAU NOVATECH02BRD25142025-02-16
14063108105254DUTAU NOVATECH02BRD35092025-02-16
14063108105261DUTAU NOVATECH02BRD35112025-02-16
14063108105278DUTAU NOVATECH02BRD35122025-02-16
14063108105285DUTAU NOVATECH02BRD35142025-02-16
14063108100921TRACHEOBRONXANE™ DUMON®04421S2024-11-22
14063108100938TRACHEOBRONXANE™ DUMON®03721S2024-11-22
14063108100945TRACHEOBRONXANE™ DUMON®03741S2024-11-22
14063108100952TRACHEOBRONXANE™ DUMON®03761S2024-11-22
14063108100969TRACHEOBRONXANE™ DUMON®03781S2024-11-22
14063108100976TRACHEOBRONXANE™ DUMON®03801S2024-11-22
14063108100983TRACHEOBRONXANE™ DUMON®03821S2024-11-22
14063108100990TRACHEOBRONXANE™ DUMON®03841S2024-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14063108100921TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100938TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100945TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100952TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100969TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100976TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100983TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100990TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101003TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101010TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101027TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101034TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101041TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101058TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101065TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101072TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101089TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101096TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101270TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101287TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101294TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101300TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101324TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101331TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101348TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101355TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101362TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101942TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22
14063108101959TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22
14063108101966TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22