Identity
- Trade Name
- SJM™ FDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Device Name
- Pericardial Patch FDA UDI
- Model / Reference
- C0405 FDA UDI
- Description
- Pericardial Patch FDA UDI
Identifiers
- Catalog Number
- C0405 FDA UDI
- Primary DI / UDI-DI
- 05414734054881 FDA UDI
- 510(k) Number
- K963967 FDA UDI
- FDA Product Code
- DXZ FDA UDI
- GMDN Term
- Cardiovascular patch, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Dimensions & Sizes
- Size
- Length — 5 Centimeter FDA UDIWidth — 4 Centimeter FDA UDI
Category: Cardiovascular patch, animal-derived
Sjm™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiovascular patch, animal-derived.
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- XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
Cleared under the same submission
K963967 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 0cfa42e9-83ac-4fc0-9ee9-68bb459c950b 38 fields · synced Jun 1, 2026