RADIFOCUS GLIDEWIRE


Product Overview

RADIFOCUS GLIDEWIRE
GLIDEWIRE - GR3810


Device Description

A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Fragile.Keep away from rain. Keep away from sunlight.

  • Device Sizes

  • Length: 150 Centimeter
  • Outer Diameter: 0.97 Millimeter
  • Flexible Tip Length: 3cm
    • Length: 150 Centimeter
    • Outer Diameter: 0.97 Millimeter
    • Flexible Tip Length: 3cm


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GCJ

    Device Name: Laparoscope, General & Plastic Surgery

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: SU

    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: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    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: 54987350773437

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 34987350773433

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 34987350773433

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350773432

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Shelfbox


    Device Id: 04987350773432

    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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