Gelweave Vascular Prostheses
- Primary DI
- 05037881169248
- Company
- VASCUTEK LTD
- Model
- 732034E
- Catalog number
- 732034E
- 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
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
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05037881169248 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 05037881169248 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 | Cardiovascular | 870.3450 | Y | Eligible |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K241550 | 000 |
Premarket Details
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. |
Device Sizes
No records found.
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 |
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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 |
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| 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 |
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| 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 |
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| 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 |
| 05037881169262 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2025-05-13 |
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| 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 |
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