Gelweave Vascular Prostheses
- Primary DI
- 05037881168791
- Brand
- Gelweave Vascular Prostheses
- Company
- VASCUTEK LTD
- Model
- 731514E
- Catalog number
- 731514E
- Device description
- Gelweave Straight
- Published
- 2025-05-13
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Cardiovascular | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K241550 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05037881168791 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Synthetic vascular graft | An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 5 Degrees Celsius | 35 Degrees Celsius |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide |
Contacts
| Phone | |
|---|---|
| +44441418125555 | tmccustomer.admin@terumomedical.com |
Regulatory Flags
- DUNS number
- 229053087
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|---|---|---|---|
| 05037881031712 | Thoraflex™ Hybrid | THP2224X100B | THP2224X100B | 2025-09-04 |
| 05037881031729 | Thoraflex™ Hybrid | THP2426X100B | THP2426X100B | 2025-09-04 |
| 05037881031736 | Thoraflex™ Hybrid | THP2628X100B | THP2628X100B | 2025-09-04 |
| 05037881031743 | Thoraflex™ Hybrid | THP2830X100B | THP2830X100B | 2025-09-04 |
| 05037881031750 | Thoraflex™ Hybrid | THP3032X100B | THP3032X100B | 2025-09-04 |
| 05037881031767 | Thoraflex™ Hybrid | THP3034X100B | THP3034X100B | 2025-09-04 |
| 05037881031774 | Thoraflex™ Hybrid | THP3036X100B | THP3036X100B | 2025-09-04 |
| 05037881031781 | Thoraflex™ Hybrid | THP3038X100B | THP3038X100B | 2025-09-04 |
| 05037881031798 | Thoraflex™ Hybrid | THP3040X100B | THP3040X100B | 2025-09-04 |
| 05037881031804 | Thoraflex™ Hybrid | THP3240X100B | THP3240X100B | 2025-09-04 |
| 05037881031811 | Thoraflex™ Hybrid | THP2224X150B | THP2224X150B | 2025-09-04 |
| 05037881031828 | Thoraflex™ Hybrid | THP2426X150B | THP2426X150B | 2025-09-04 |
| 05037881031835 | Thoraflex™ Hybrid | THP2628X150B | THP2628X150B | 2025-09-04 |
| 05037881031842 | Thoraflex™ Hybrid | THP2830X150B | THP2830X150B | 2025-09-04 |
| 05037881031859 | Thoraflex™ Hybrid | THP3032X150B | THP3032X150B | 2025-09-04 |
| 05037881031866 | Thoraflex™ Hybrid | THP3034X150B | THP3034X150B | 2025-09-04 |
| 05037881031873 | Thoraflex™ Hybrid | THP3036X150B | THP3036X150B | 2025-09-04 |
| 05037881031880 | Thoraflex™ Hybrid | THP3038X150B | THP3038X150B | 2025-09-04 |
| 05037881031897 | Thoraflex™ Hybrid | THP3040X150B | THP3040X150B | 2025-09-04 |
| 05037881031903 | Thoraflex™ Hybrid | THP3240X150B | THP3240X150B | 2025-09-04 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05037881114040 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881114057 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166506 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166513 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166759 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166773 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166827 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166919 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166964 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881166988 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881167015 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881167053 | Gelsoft Plus Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881168609 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881168661 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881168753 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881168814 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881168951 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881168999 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169019 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169187 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169194 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169248 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169262 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169286 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169316 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169323 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169385 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169392 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169590 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
| 05037881169637 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |