NEEDLE EP003994S BROCKENBROUGH ADULT


Product Overview

NEEDLE EP003994S BROCKENBROUGH ADULT
NA - EP003994S


Device Description

A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 57.00
    • -34.00

  • Device Sizes

  • Length: 71.0 Centimeter
  • Outer Diameter: 1.02 Millimeter
    • Length: 71.0 Centimeter
    • Outer Diameter: 1.02 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DRC

    Device Name: Trocar

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: N

    Target Area: N/A

    Regulation Number: 870.1390

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00613994663146

    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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