GORE ACUSEAL Vascular Graft
- Primary DI
- 00733132634811
- Brand
- GORE ACUSEAL Vascular Graft
- Company
- W. L. Gore & Associates, Inc.
- Model
- ECH460045A
- Catalog number
- ECH460045A
- Device description
- GORE ACUSEAL VASCULAR GRAFT 4-6mmX45cm Tapered Heparin
- Published
- 2016-10-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
wlgore.comProduct Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K130215 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00733132634811 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00733132634811 | 00733132634811 | 733132634811 | 0733132634811 |
GMDN Terms#
| Term | Definition |
|---|---|
| Synthetic vascular graft | A sterile 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#
| Type | Value | Unit |
|---|---|---|
| Length | 45 | Centimeter |
| Lumen/Inner Diameter | 4 | Millimeter |
| Lumen/Inner Diameter | 6 | Millimeter |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)528-8763 | mpdcustomercare@wlgore.com |
Regulatory Flags#
- DUNS number
- 967358115
- Device count
- 1
- Combination product
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00733132658855 | GORE® DrySeal Flex Introducer Sheath | GDSF1033 | GDSF1033 | 2024-12-02 |
| 00733132658862 | GORE® DrySeal Flex Introducer Sheath | GDSF1045 | GDSF1045 | 2024-12-02 |
| 00733132658879 | GORE® DrySeal Flex Introducer Sheath | GDSF1065 | GDSF1065 | 2024-12-02 |
| 00733132658886 | GORE® DrySeal Flex Introducer Sheath | GDSF1133 | GDSF1133 | 2024-12-02 |
| 00733132658893 | GORE® DrySeal Flex Introducer Sheath | GDSF1233 | GDSF1233 | 2024-12-02 |
| 00733132658909 | GORE® DrySeal Flex Introducer Sheath | GDSF1245 | GDSF1245 | 2024-12-02 |
| 00733132658916 | GORE® DrySeal Flex Introducer Sheath | GDSF1265 | GDSF1265 | 2024-12-02 |
| 00733132658923 | GORE® DrySeal Flex Introducer Sheath | GDSF1433 | GDSF1433 | 2024-12-02 |
| 00733132658930 | GORE® DrySeal Flex Introducer Sheath | GDSF1465 | GDSF1465 | 2024-12-02 |
| 00733132658947 | GORE® DrySeal Flex Introducer Sheath | GDSF1533 | GDSF1533 | 2024-12-02 |
| 00733132658954 | GORE® DrySeal Flex Introducer Sheath | GDSF1633 | GDSF1633 | 2024-12-02 |
| 00733132658961 | GORE® DrySeal Flex Introducer Sheath | GDSF1665 | GDSF1665 | 2024-12-02 |
| 00733132658978 | GORE® DrySeal Flex Introducer Sheath | GDSF1833 | GDSF1833 | 2024-12-02 |
| 00733132658985 | GORE® DrySeal Flex Introducer Sheath | GDSF1865 | GDSF1865 | 2024-12-02 |
| 00733132658992 | GORE® DrySeal Flex Introducer Sheath | GDSF2033 | GDSF2033 | 2024-12-02 |
| 00733132659005 | GORE® DrySeal Flex Introducer Sheath | GDSF2065 | GDSF2065 | 2024-12-02 |
| 00733132659012 | GORE® DrySeal Flex Introducer Sheath | GDSF2233 | GDSF2233 | 2024-12-02 |
| 00733132659029 | GORE® DrySeal Flex Introducer Sheath | GDSF2265 | GDSF2265 | 2024-12-02 |
| 00733132659036 | GORE® DrySeal Flex Introducer Sheath | GDSF2433 | GDSF2433 | 2024-12-02 |
| 00733132659043 | GORE® DrySeal Flex Introducer Sheath | GDSF2465 | GDSF2465 | 2024-12-02 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05037881184883 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2026-05-22 |
| 05037881184890 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2026-05-22 |
| 05037881184906 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2026-05-22 |
| 05037881184913 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2026-05-22 |
| 05037881184920 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2026-05-22 |
| 05037881184937 | Gelweave Vascular Prostheses | VASCUTEK LTD | DSY | 2026-05-22 |
| 00733132600038 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132600052 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132600076 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132600090 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132605354 | GORE ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132605354 | GORE ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606290 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132606290 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606313 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132606313 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606351 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606351 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132606375 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606375 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132606399 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606399 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132606436 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606436 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132607068 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607068 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132607129 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607129 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132607143 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DYF | 2017-02-13 |
| 00733132607143 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |