Introducer Sheath Set


Product Overview

Introducer Sheath Set
ClosureFast - IS-7F11


Device Description

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 11 Centimeter
  • Catheter Gauge: 7 French
    • Length: 11 Centimeter
    • Catheter Gauge: 7 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DRE

    Device Name: Dilator, Vessel, For Percutaneous Catheterization

    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: 870.1310

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 20884521140308

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521140301

    Package Quantity: 100

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PACK_OR_INNER_PACK


    Device Id: 10884521140301

    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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