Product Overview

Hood
Flyte - 0408800000


Device Description

A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 49.00
    • N/A

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FYA

    Device Name: Gown, Surgical

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    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: 878.4040

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 34546540591716

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04546540591715

    Package Quantity: 32

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: pack


    Device Id: 04546540591715

    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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