KD-27Q-1.B PUSH TYPE SPHINCTEROTOME W/ST


Product Overview

KD
PAPILLOTOMY KNIFE - KD-27Q-1


Device Description

An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

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


    Product Codes

    Code: KNS

    Device Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    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: 876.4300

    Third Party Flag: Y

    Medical Specialty: GU


    Device Identifiers

    Device Id: 14953170038706

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04953170038709

    Package Quantity: 1

    Package Discontinue Date: 8/10/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: N/A


    Device Id: 04953170038709

    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


    Device Id: 84953170038705

    Device Type: Unit of Use

    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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