FDA UDI
In Commercial Distribution
🇺🇸 United States
Thoraflex™ Hybrid
DI: 05037881031736
·
Model: THP2628X100B
·
VASCUTEK LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thoraflex™ Hybrid
- Primary DI
- 05037881031736
- Version / Model
- THP2628X100B
- Catalog Number
- THP2628X100B
- Company Name
- VASCUTEK LTD
- Labeler DUNS
- 229053087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-04
- Public Version
- 3
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- b10fc104-1911-4ceb-b7da-04501daf6ca8
Device Description
Thoraflex Hybrid Plexus
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QSK | Hybrid stent graft, thoracic aortic lesion treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35281 | Synthetic vascular graft, non-medicated | An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05037881031736 | GS1 |
Customer Contacts
- Phone
- +44441418125555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210006 | 000 |
| P210006 | 001 |
| P210006 | 002 |
| P210006 | 003 |
| P210006 | 004 |
| P210006 | 005 |
| P210006 | 006 |
| P210006 | 007 |
| P210006 | 009 |
| P210006 | 010 |
| P210006 | 011 |
| P210006 | 012 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Length | 100 | Millimeter | |
| Stent Diameter | 28 | Millimeter |