Identity
- Trade Name
- VasCure for Carotid Repair EUDAMEDFDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Device Name
- VasCure for Carotid Repair, Single Pack, 1 cm X 10 cm, OUS EUDAMEDVasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing. FDA UDI
- Model / Reference
- CMCV-073-609 EUDAMEDFDA UDI
- Description
- VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859389005096 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00859389005096 EUDAMED
- 510(k) Number
- K111187 FDA UDI
- FDA Product Code
- DXZ FDA UDI
- EMDN Code
- P07020102 SIS (SMALL INTESTINAL SUBMUCOSA) VASCULAR PATCHES EUDAMED
- GMDN Term
- Cardiovascular patch, animal-derived FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3470 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 1 Centimeter FDA UDIWidth — 10 Centimeter FDA UDI
VasCure for Carotid Repair by Aziyo Biologics, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00859389005096 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Aziyo Biologics, Inc.
- EUDAMED SRN
- US-MF-000003634
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 4e385498-48d4-427c-ba08-226bcefcd811 61 fields · synced Jul 26, 2026
- FDA UDI b973391b-ac9b-492c-ae7d-5dbe7ea8f6c0 37 fields · synced May 30, 2026