TRACHEOBRONXANE™ DUMON® RADIOPAQUE

GUDID 14063108101478

Tracheo-bronchial silicone stent, TD 12 L 80 ORX

NOVATECH

Polymeric tracheal/bronchial stent, non-bioabsorbable

• Primary Device ID: 14063108101478
• NIH Device Record Key: 022c87c4-b130-4cd1-b494-8166ae0092bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACHEOBRONXANE™ DUMON® RADIOPAQUE
• Version Model Number: 03231RS
• 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	14063108101478 [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® RADIOPAQUE]

• 14063108108330: ST 14-12-14 L 15-20-15
• 14063108108064: BD 09 L 70
• 14063108107333: BD 11 L 60
• 14063108107050: TD 16 L 60
• 14063108107029: TF 16 L 50
• 14063108106985: TF 16 L 40
• 14063108106930: TD 16 L 30
• 14063108106831: TD 15 L 70
• 14063108106510: TF 14 L 40
• 14063108106343: TF 13 L 60
• 14063108106152: TD 12 L 70
• 14063108100181: TD 13 L 60
• 14063108107982: BD 09 L 30
• 14063108107906: TF 16 L 90
• 14063108107104: TF 16 L 70
• 14063108106879: TD 15 L 90
• 14063108106787: TD 15 L 50
• 14063108106626: TD 14 L 70
• 14063108106473: TF 14 L 30
• 14063108106381: TD 13 L 70
• 14063108108729: TF 13 L 40
• 14063108108293: ST 16-14-16 L 15-20-15
• 14063108108026: BD 09 L 50
• 14063108107968: TD 16 L 110
• 14063108107944: TF 16 L 100
• 14063108107937: TD 16 L 100
• 14063108107890: TD 16 L 90
• 14063108107869: TF 16 L 80
• 14063108107852: TD 16 L 80
• 14063108107548: TD 18 L 50
• 14063108107517: TD 18 L 40
• 14063108107456: BD 12 L 70
• 14063108107432: BD 12 L 60
• 14063108107418: BD 12 L 50
• 14063108107395: BD 12 L 40
• 14063108107371: BD 12 L 30
• 14063108107296: BD 11 L 40
• 14063108107180: BD 10 L 50
• 14063108107166: BD 10 L 40
• 14063108107128: BD 10 L 20
• 14063108107098: TD 16 L 70
• 14063108107067: TF 16 L 60
• 14063108107012: TD 16 L 50
• 14063108106978: TD 16 L 40
• 14063108106855: TD 15 L 80
• 14063108106817: TD 15 L 60
• 14063108106756: TD 15 L 40
• 14063108106725: TF 15 L 30
• 14063108106718: TD 15 L 30
• 14063108106688: TD 15 L 110