PROSTAR XL10F Percutaneous Vascular Surgical System


Product Overview

PROSTAR XL10F Percutaneous Vascular Surgical System
Prostar - 12322-01


Device Description

A collection of hand-operated instruments designed for the percutaneous delivery of sutures to close a femoral artery or vein puncture site following a catheterization procedure; it is intended to reduce the time to haemostasis and ambulation for the patient. The collection typically consists of a sheath containing suture needles with sutures, needle guide, and a marker to control the placement of needles around the puncture site; and a suture knot pusher. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep dry. Store in a cool place (room temperature).

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MGB

    Device Name: Device, Hemostasis, Vascular

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    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: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 28717648000625

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 08717648000621

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 08717648000621

    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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