GORE® ACUSEAL Cardiovascular Patch
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- GORE® ACUSEAL Cardiovascular Patch EUDAMEDFDA UDI
- Generic Name
- Cardiovascular patch, synthetic FDA UDI
- Device Name
- GORE® ACUSEAL Cardiovascular Patch EUDAMEDACUSEAL CARDIOVASCULAR PATCH 3.0cmX3.0cmX0.5mm FDA UDIACUSEAL CARDIOVASCULAR PATCH 2.5cmX15.0cmX0.5mm FDA UDI
- Model / Reference
- 1CVX103 EUDAMEDFDA UDI1CVX004 EUDAMEDFDA UDI
- Description
- ACUSEAL CARDIOVASCULAR PATCH 3.0cmX3.0cmX0.5mm FDA UDIACUSEAL CARDIOVASCULAR PATCH 2.5cmX15.0cmX0.5mm FDA UDI
Identifiers
- Catalog Number
- 1CVX103 FDA UDI1CVX004 FDA UDI
- Primary DI / UDI-DI
- 00733132600946 EUDAMEDFDA UDI00733132600915 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00733132600915 EUDAMEDB-00733132600946 EUDAMED
- 510(k) Number
- K984526 FDA UDI
- FDA Product Code
- DXZ FDA UDI
- EMDN Code
- P07020202 PTFE VASCULAR PATCHES EUDAMED
- GMDN Term
- Cardiovascular patch, synthetic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Height — .5 Millimeter FDA UDIWidth — 3 Centimeter FDA UDILength — 3 Centimeter FDA UDIHeight — .5 Centimeter FDA UDIWidth — 2.5 Centimeter FDA UDILength — 15 Centimeter FDA UDI
Category: Cardiovascular patch, synthetic
GORE® ACUSEAL Cardiovascular Patch by W. L. Gore & Associates, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- W. L. Gore & Associates, Inc
Sources (4)
- FDA UDI 3d590f93-e015-4708-a017-eed4efce12f6 37 fields · synced Jul 22, 2026
- FDA UDI b3898001-41fb-4030-a4e4-d139daf8992a 37 fields · synced May 30, 2026
- EUDAMED 908707dd-8b0e-4869-94a0-d4a9bedd3467 61 fields · synced Jul 9, 2026
- EUDAMED e88ffb77-1bfa-4738-8a64-c0148f234d56 61 fields · synced Jul 22, 2026