Identity
- Trade Name
- PhotoFix Decellularized Bovine Pericardium FDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Device Name
- Decellularized Bovine Pericardium FDA UDI
- Model / Reference
- PFP1X14 FDA UDI
- Description
- Decellularized Bovine Pericardium FDA UDI
Identifiers
- Catalog Number
- PFP1X14 FDA UDI
- Primary DI / UDI-DI
- 00877234000645 FDA UDI
- FDA Product Code
- PSQ 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
- Width — 1 Centimeter FDA UDILength — 14 Centimeter FDA UDI
Category: Cardiovascular patch, animal-derived
PhotoFix Decellularized Bovine Pericardium by Artivion, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiovascular patch, animal-derived.
- Biotronik BioEnvelope — Elutia Med LLC · Class II
- XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
- CardioCel Bioscaffold Patch 5 cm X 8 cm — LeMaitre Vascular, Inc. · Class II
- VASCU-GUARD Peripheral Vascular Patch — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Invengenx — Tisgenx · Class II
- VascuCel — ADMEDUS REGEN PTY LTD · Class II
- AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II
- XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Artivion, Inc.
Sources (2)
- FDA UDI 92fc0faa-9df0-495a-aef1-f2844fd9f26c 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026