Zenith Alpha ZTA-PT-22-18-105-W
GUDID 10827002380414
Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component
William Cook Europe ApS
Synthetic vascular graft| Primary Device ID | 10827002380414 |
| NIH Device Record Key | 37c30496-d2a7-483c-a782-d3bb1f57ee43 |
| Commercial Distribution Discontinuation | 2017-06-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Zenith Alpha |
| Version Model Number | G38041 |
| Catalog Number | ZTA-PT-22-18-105-W |
| Company DUNS | 305302119 |
| Company Name | William Cook Europe ApS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Customer Support Contacts
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10827002380414 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140016
FDA Product Code
| MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [Zenith Alpha]
| 10827002382364 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002382203 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002382166 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002382081 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002382043 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002382036 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002382012 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381916 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381909 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381800 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381794 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381787 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381732 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381725 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002381718 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002380759 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002380728 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002380551 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002380414 | Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component |
| 10827002380285 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002380278 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002380254 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002380247 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002380230 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002363462 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355269 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355252 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355245 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355238 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355221 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355214 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355207 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355191 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355184 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355177 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355160 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355153 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355146 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355139 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355122 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355115 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355108 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355092 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355078 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355061 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355054 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355047 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355030 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002355023 | Zenith Alpha, Thoracic Endovascular Graft, Distal Extension |
| 10827002354040 | Zenith Alpha, Thoracic Endovascular Graft, Distal Component |
Trademark Results [Zenith Alpha]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZENITH ALPHA 85847093 5045833 Live/Registered |
Cook Medical Technologies LLC 2013-02-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.