GW WWIJ35300 WHOLEY WIRE V03


Product Overview

GW WWIJ35300 WHOLEY WIRE V03
Wholey™ - WWIJ35300


Device Description

A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep away from sunlight
  • Special Storage Condition, Specify
    • Keep Dry

  • Device Sizes

  • Length: 300 Centimeter
  • Outer Diameter: 0.089 CM
    • Length: 300 Centimeter
    • Outer Diameter: 0.089 CM


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DQX

    Device Name: Wire, Guide, 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: 870.1330

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00821684058671

    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


    Device Id: 00821684065945

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00821684058671

    Package Quantity: 3

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PK


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