Identity
- Trade Name
- CardioCel Bioscaffold Patch 6 cm X 14 cm FDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Model / Reference
- UC0614C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840663110575 FDA UDI
- 510(k) Number
- K130872 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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiovascular patch, animal-derived
CardioCel Bioscaffold Patch 6 cm X 14 cm by LeMaitre Vascular, 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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Cleared under the same submission
K130872 also covers:
- CardioCel — ADMEDUS REGEN PTY LTD
- CardioCel — ADMEDUS REGEN PTY LTD
- CardioCel — ADMEDUS REGEN PTY LTD
- CardioCel — ADMEDUS REGEN PTY LTD
- CardioCel — ADMEDUS REGEN PTY LTD
- CardioCel — ADMEDUS REGEN PTY LTD
- CardioCel — ADMEDUS REGEN PTY LTD
- CardioCel Agile — ADMEDUS REGEN PTY LTD
- CardioCel Agile — ADMEDUS REGEN PTY LTD
- CardioCel Cardiovascular Patch — ADMEDUS REGEN PTY LTD
- CardioCel Cardiovascular Patch — ADMEDUS REGEN PTY LTD
- CardioCel Cardiovascular Patch — ADMEDUS REGEN PTY LTD
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
- LeMaitre Vascular, Inc.
Sources (1)
- FDA UDI 0f69b29f-96ca-4247-aff6-cf44cee5d1c2 33 fields · synced Jun 9, 2026