Thoraflex™ Hybrid THP2628X100A
GUDID 05037881026701
Thoraflex Hybrid Plexus 4 Hybrid Stent Device
VASCUTEK LTD
Fluoroscopic x-ray system video image recording unit| Primary Device ID | 05037881026701 |
| NIH Device Record Key | d8bc85a3-83c5-41c6-ae61-a39df0f2e1c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thoraflex™ Hybrid |
| Version Model Number | THP2628X100A |
| Catalog Number | THP2628X100A |
| Company DUNS | 229053087 |
| Company Name | VASCUTEK LTD |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 242100 Millimeter |
| Lumen/Inner Diameter | 26 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place out of direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05037881026701 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P210006
FDA Product Code
| QSK | Hybrid stent graft, thoracic aortic lesion treatment |
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 | 2022-06-08 |
| Device Publish Date | 2022-05-31 |
On-Brand Devices [Thoraflex™ Hybrid]
| 05037881027081 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027074 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027067 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027050 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027043 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027036 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027029 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027012 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881027005 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026992 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026985 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026978 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026961 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026954 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026947 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026930 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026923 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026916 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026909 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026893 | Thoraflex Hybrid Ante-Flo Hybrid Stent Device |
| 05037881026879 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026862 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026855 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026848 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026831 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026824 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026817 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026800 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026794 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026787 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026770 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026763 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026756 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026749 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026732 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026725 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026718 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026701 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026695 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
| 05037881026626 | Thoraflex Hybrid Plexus 4 Hybrid Stent Device |
Trademark Results [Thoraflex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THORAFLEX 97673743 not registered Live/Pending |
Vascutek Limited 2022-11-11 |
 THORAFLEX 79081392 4235676 Live/Registered |
Vascutek Limited 2010-02-19 |
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