THV 1000-23 3F AORTIC BIO 23MM

Product Overview

THV 1000
3f® - 1000-23

Device Description

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.

Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 5.00

  • Device Sizes

  • Valve Inner Diameter 23 MM
  • Valve Height 27 MM
    • Valve Inner Diameter 23 MM
    • Valve Height 27 MM

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: LWR

    Device Name: Heart-Valve, Non-Allograft Tissue

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    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: N/A

    Third Party Flag: N

    Medical Specialty: N/A

    Device Identifiers

    Device Id: 00613994868237

    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