RING SIM SR 800SR34 SEMI-RIGID 34MM


Product Overview

RING SIM SR 800SR34 SEMI
ATS Tri-Ad® - 800SR34


Device Description

A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
  • Special Storage Condition, Specify
    • Store in cool dry place.

  • Device Sizes

  • Lumen/Inner Diameter: 34.0 Millimeter
    • Lumen/Inner Diameter: 34.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KRH

    Device Name: Ring, Annuloplasty

    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: 870.3800

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00643169301023

    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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