CryoPatch SG Pulmonary Hemi-Artery The CryoPatch SG Pulmonary Human Cardiac Patch is a human heart valve aseptically recovered from donated human tissue.

Product Overview

CryoPatch SG Pulmonary Hemi
CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch - SGPH00

Device Description

An implantable heart tissue allograft obtained from a human cadaver intended to be implanted in the heart during open heart surgery, to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be supplied in various configurations including pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

Environmental Conditions

  • Special Storage Condition, Specify
    • At or Below -135 degrees Celsius

  • Device Sizes

  • Branch Length: 1.0cm (minimum) (allograft specific)
  • Proximal Base: 30mm (minimum) (allograft specific)
    • Branch Length: 1.0cm (minimum) (allograft specific)
    • Proximal Base: 30mm (minimum) (allograft specific)

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: DXZ

    Device Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 870.3470

    Third Party Flag: N

    Medical Specialty: CV

    Device Identifiers

    Device Id: 00877234000461

    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

    Educational Resources