TRACHEOBRONXANE™ DUMON™ RADIO OPAQUE 09401R
GUDID EBES09401R0
Y 18-14-14 SUR BAF
NOVATECH
Polymeric tracheal/bronchial stent, non-bioabsorbable, sterile Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable| Primary Device ID | EBES09401R0 |
| NIH Device Record Key | 4d02a52c-1c66-4889-878f-0765ce653f9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACHEOBRONXANE™ DUMON™ RADIO OPAQUE |
| Version Model Number | 09401R |
| Catalog Number | 09401R |
| 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 | |
| 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 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 |
| 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 | EBES09401R0 [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 |
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
[EBES09401R0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-30 |
On-Brand Devices [TRACHEOBRONXANE™ DUMON™ RADIO OPAQUE]
| EBES09401R0 | Y 18-14-14 SUR BAF |
| EBES094011R0 | Y 18-14-14 L 110-50-50 |
| EBES09301R0 | Y 16-13-13 SUR BAF |
| EBES093011R0 | Y 16-13-13 L 110-50-50 |
| EBES09201R0 | Y 15-12-12 SUR BAF |
| EBES092011R0 | Y 15-12-12 L 110-50-50 |
| EBES09101R0 | Y 14-10-10 SUR BAF |
| EBES091011R0 | Y 14-10-10 L 110-50-50 |
| EBES09061R0 | ST 18-16-18 L 15-20-15 |
| EBES09051R0 | ST 15-13-15 L 15-20-15 |
| EBES09041R0 | ST 12-10-12 L 15-20-15 |
| EBES09031R0 | ST 14-12-14 L 15-20-15 |
| EBES09011R0 | ST 16-14-16 L 15-20-15 |
| EBES090031R0 | YB 15-12-12 L 50-20-30 |
| EBES090021R0 | Y 15-12-12 L 50-30-30 |
| EBES09001R0 | YB 16-13-13 L 20-15-21 |
| EBES06301R0 | CB 12 L 50 |
| EBES06281R0 | CB 12 L 40 |
| EBES06261R0 | CB 12 L 30 |
| EBES06181R0 | CB 11 L 50 |
| EBES06161R0 | CB 11 L 40 |
| EBES06061R0 | CB 10 L 50 |
| EBES06041R0 | CB 10 L 40 |
| EBES06031R0 | CB 10 L 30 |
| EBES06001R0 | CB 10 L 20 |
| EBES05941R0 | CB 09 L 50 |
| EBES05921R0 | CB 09 L 40 |
| EBES05901R0 | CB 09 L 30 |
| EBES05881R0 | CB 09 L 20 |
| EBES05101R0 | BO 12 L 50 |
| EBES05081R0 | BO 12 L 40 |
| EBES05061R0 | BO 12 L 30 |
| EBES04981R0 | BO 11 L 50 |
| EBES04961R0 | BO 11 L 40 |
| EBES04941R0 | BO 11 L 30 |
| EBES04921R0 | BO 11 L 20 |
| EBES04861R0 | BO 10 L 50 |
| EBES04841R0 | BO 10 L 40 |
| EBES04821R0 | BO 10 L 30 |
| EBES04801R0 | BO 10 L 20 |
| EBES04781R0 | BO 09 L 60 |
| EBES04761R0 | BO 09 L 50 |
| EBES04741R0 | BO 09 L 40 |
| EBES04451RF0 | TF 20 L 110 |
| EBES04421R0 | BD 09 L 70 |
| EBES04411R0 | BD 09 L 60 |
| EBES04391R0 | BD 09 L 50 |
| EBES04371R0 | BD 09 L 40 |
| EBES04341R0 | BD 09 L 30 |
| EBES04311R0 | TD 16 L 110 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.