STYLET 628285 US DS KNOB ST


Product Overview

STYLET 628285 US DS KNOB ST
NA - 628285


Device Description

A sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Outer Diameter: 0.356 Millimeter
  • Length: 85.0 Centimeter
    • Outer Diameter: 0.356 Millimeter
    • Length: 85.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DRB

    Device Name: Stylet, Catheter

    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: N

    Target Area: N/A

    Regulation Number: 870.1380

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 20613994618669

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00613994618665

    Package Quantity: 5

    Package Discontinue Date: 5/10/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: PK


    Device Id: 00613994618665

    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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