VALVULOTOME (DETACHABLE TYPE)


Product Overview

VALVULOTOME (DETACHABLE TYPE)
VALVULOTOME (DETACHABLE TYPE) - C-0104B


Device Description

A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: DWX

    Device Name: Stripper, Artery, Intraluminal

    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: 870.4875

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 14953170047692

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04953170047695

    Package Quantity: 1

    Package Discontinue Date: 8/15/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: N/A


    Device Id: 04953170047695

    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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