DRILL 3334800 VISAO 80K HANDPIECE ROHS


Product Overview

DRILL 3334800 VISAO 80K HANDPIECE ROHS
VISAO® - 3334800


Device Description

A pneumatically-powered (gas-powered) component of a surgical power tool system intended to regulate the gas pressure supplied to the pneumatic handpiece/motor (not included) and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Ethylene Oxide
  • Moist Heat or Steam Sterilization
    • Ethylene Oxide
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: ERL

    Device Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: EN

    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: 874.4250

    Third Party Flag: Y

    Medical Specialty: EN


    Device Identifiers

    Device Id: 00643169360938

    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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