TRACHEOBRONXANE™ DUMON®

GUDID 14063108100099

Tracheo-bronchial silicone stent, TD 12 L 40

NOVATECH

Polymeric tracheal/bronchial stent, non-bioabsorbable

• Primary Device ID: 14063108100099
• NIH Device Record Key: 0928f3ca-0f61-4f88-98c7-41fd170946b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACHEOBRONXANE™ DUMON®
• Version Model Number: 03161S
• Company DUNS: 777211640
• Company Name: NOVATECH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	14063108100099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243126

FDA Product Code

• NWA: Prosthesis, Tracheal, Preformed/Molded

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [TRACHEOBRONXANE™ DUMON®]

• 14063108108590: Y 18-14-14 L 110-50-50
• 14063108108538: Y 16-13-13 L 110-50-50
• 14063108108477: Y 15-12-12 L 110-50-50
• 14063108108422: Y 14-10-10 L 110-50-50
• 14063108108361: ST 15-13-15 L 15-20-15
• 14063108107883: TF 16 L 90
• 14063108107760: TF 20 L 60
• 14063108107692: TF 18 L 100
• 14063108107661: TF 18 L 90
• 14063108107623: TF 18 L 80
• 14063108107357: BD 12 L 20
• 14063108107241: BD 11 L 20
• 14063108107111: BD 10 L 20
• 14063108107043: TF 16 L 60
• 14063108106848: TD 15 L 80
• 14063108106701: TD 15 L 30
• 14063108106527: TD 14 L 50
• 14063108106442: TD 14 L 30
• 14063108106374: TF 13 L 70
• 14063108106336: TF 13 L 60
• 14063108105995: TD 11 L 70
• 14063108105896: TD 11 L 20
• 14063108108347: ST 12-10-12 L 15-20-15
• 14063108108088: TF 20 L 100
• 14063108107951: TD 16 L 110
• 14063108107845: TF 16 L 80
• 14063108107746: TF 20 L 50
• 14063108107524: TD 18 L 50
• 14063108107388: BD 12 L 40
• 14063108106992: TD 16 L 50
• 14063108106954: TD 16 L 40
• 14063108106862: TD 15 L 90
• 14063108106329: TD 13 L 60
• 14063108106237: TF 13 L 30
• 14063108106220: TD 13 L 30
• 14063108106015: TD 12 L 20
• 14063108108385: ST 18-16-18 L 15-20-15
• 14063108108323: ST 14-12-14 L 15-20-15
• 14063108108286: ST 16-14-16 L 15-20-15
• 14063108108095: TF 20 L 110
• 14063108108071: TF 20 L 90
• 14063108108033: BD 09 L 60
• 14063108107999: BD 09 L 40
• 14063108107975: BD 09 L 30
• 14063108107920: TF 16 L 100
• 14063108107913: TD 16 L 100
• 14063108107876: TD 16 L 90
• 14063108107784: TF 20 L 70
• 14063108107500: TF 18 L 40
• 14063108107494: TD 18 L 40