SHEATH 197230BVA 5PK ES2 STZ REV 4MM/30D


Product Overview

SHEATH 197230BVA 5PK ES2 STZ REV 4MM/30D
ENDO-SCRUB® - 197230BVA


Device Description

A device designed to fit over the distal end of a non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use, to act as a cover/shield to avoid direct contact to the eye and/or cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid partially- or fully- transparent plastic device. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Angle: 30.0 degree
  • Lumen/Inner Diameter: 4.0 Millimeter
    • Angle: 30.0 degree
    • Lumen/Inner Diameter: 4.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: EOB

    Device Name: Nasopharyngoscope (Flexible Or Rigid)

    Device Class: 2

    Physical State: N/A

    Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    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: 874.4760

    Third Party Flag: Y

    Medical Specialty: EN


    Device Identifiers

    Device Id: 20613994661962

    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: 00613994661968

    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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