TRACHEOBRONXANE™ DUMON™ 04181F
GUDID EBES04181F0
TF 18 L 80
NOVATECH
Polymeric tracheal/bronchial stent, non-bioabsorbable| Primary Device ID | EBES04181F0 |
| NIH Device Record Key | 116e29e8-fb7d-4f48-b0fe-9ce1d9c3abf4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACHEOBRONXANE™ DUMON™ |
| Version Model Number | 04181F |
| Catalog Number | 04181F |
| Company DUNS | 777211640 |
| Company Name | NOVATECH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr | |
| Phone | +33442981560 |
| info@novatech.fr |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBES04181F0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K971509
FDA Product Code
| NWA | Prosthesis, Tracheal, Preformed/Molded |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
[EBES04181F0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-25 |
| Device Publish Date | 2021-03-17 |
On-Brand Devices [TRACHEOBRONXANE™ DUMON™]
| EBES0940110 | Y 18-14-14 L 110-50-50 |
| EBES094010 | Y 18-14-14 SUR BAF |
| EBES0930110 | Y 16-13-13 L 110-50-50 |
| EBES093010 | Y 16-13-13 SUR BAF |
| EBES0920110 | Y 15-12-12 L 110-50-50 |
| EBES092010 | Y 15-12-12 SUR BAF |
| EBES0910110 | Y 14-10-10 L 110-50-50 |
| EBES091010 | Y 14-10-10 SUR BAF |
| EBES090610 | ST 18-16-18 L 15-20-15 |
| EBES090510 | ST 15-13-15 L 15-20-15 |
| EBES090410 | ST 12-10-12 L 15-20-15 |
| EBES090310 | ST 14-12-14 L 15-20-15 |
| EBES09011SC0 | ST SPECIALE |
| EBES090110 | ST 16-14-16 L 15-20-15 |
| EBES0900310 | YB 15-12-12 L 50-20-30 |
| EBES0900210 | Y 15-12-12 L 50-30-30 |
| EBES090010 | YB 16-13-13 L 20-15-21 |
| EBES09000SC0 | Y SPECIALE |
| EBES063110 | CB 12 L 60 |
| EBES063010 | CB 12 L 50 |
| EBES062810 | CB 12 L 40 |
| EBES062610 | CB 12 L 30 |
| EBES062410 | CB 12 L 20 |
| EBES061810 | CB 11 L 50 |
| EBES061610 | CB 11 L 40 |
| EBES061210 | CB 11 L 20 |
| EBES060610 | CB 10 L 50 |
| EBES060410 | CB 10 L 40 |
| EBES060210 | CB 10 L 30 |
| EBES060010 | CB 10 L 20 |
| EBES059410 | CB 09 L 50 |
| EBES059210 | CB 09 L 40 |
| EBES059010 | CB 09 L 30 |
| EBES058810 | CB 09 L 20 |
| EBES051210 | BO 12 L 60 |
| EBES051010 | BO 12 L 50 |
| EBES050810 | BO 12 L 40 |
| EBES050610 | BO 12 L 30 |
| EBES050410 | BO 12 L 20 |
| EBES049810 | BO 11 L 50 |
| EBES049610 | BO 11 L 40 |
| EBES049410 | BO 11 L 30 |
| EBES049210 | BO 11 L 20 |
| EBES048810 | BO 10 L 60 |
| EBES048610 | BO 10 L 50 |
| EBES048410 | BO 10 L 40 |
| EBES048210 | BO 10 L 30 |
| EBES048010 | BO 10 L 20 |
| EBES047410 | BO 09 L 40 |
| EBES047010 | BO 09 L 20 |
Trademark Results [TRACHEOBRONXANE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACHEOBRONXANE 76499541 2829546 Dead/Cancelled |
Novatech SA 2003-03-21 |
 TRACHEOBRONXANE 75699748 not registered Dead/Abandoned |
NOVATECH SA 1999-05-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.