VISIGLIDE2 Single Use Guidewire


Product Overview

VISIGLIDE2 Single Use Guidewire
VISIGLIDE2 - G-260-3545A


Device Description

A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Fragile. Keep dry. Keep away from sunlight. Stacking limit by 7.

  • Device Sizes

  • Adaptable type : 0.035 inch
  • Length: 4500 Millimeter
  • Hydrophilic Coating Length : 70mm
    • Adaptable type : 0.035 inch
    • Length: 4500 Millimeter
    • Hydrophilic Coating Length : 70mm


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OCY

    Device Name: Endoscopic Guidewire, Gastroenterology-Urology

    Device Class: 2

    Physical State: metal guidewire with or without polymer coating, and associated guidewire accessories

    Definition: To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

    Submission Type ID: 4

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: placed through working channel of endoscope

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: various in GI and GU tract

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 54953170358260

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04953170358265

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 04953170358265

    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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