Decellularized Bovine Pericardium

Product Overview

Decellularized Bovine Pericardium
PhotoFix Decellularized Bovine Pericardium - PFP1X6

Device Description

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Environmental Conditions

  • Special Storage Condition, Specify
    • Do not place the pericardium in areas where significant temperature fluctuations occur.
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 5.00

  • Device Sizes

  • Width: 1 Centimeter
  • Length: 6 Centimeter
    • Width: 1 Centimeter
    • Length: 6 Centimeter

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: PSQ

    Device Name: Intracardiac Patch Or Pledget, Biologically Derived

    Device Class: 2

    Physical State: The device is a biologic tissue, typically in the form of a sheet. The tissue may be decellularized or crosslinked, and may be derived from human or animal sources.

    Definition: To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The device is sutured into the intended site to repair or support the native tissue.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Heart and vasculature

    Regulation Number: 870.3470

    Third Party Flag: N

    Medical Specialty: CV

    Device Identifiers

    Device Id: 00877234000539

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

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