BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Operating Room Innovations, Inc

    DI: 00854150007361 · Model: OH-4 · OPERATING ROOM INNOVATIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Operating Room Innovations, Inc
    Primary DI
    00854150007361
    Version / Model
    OH-4
    Catalog Number
    OH-4
    Company Name
    OPERATING ROOM INNOVATIONS, INC.
    Labeler DUNS
    080246656
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-23
    Public Version
    1
    Public Version Date
    2021-10-01
    Public Version Status
    New
    Public Device Record Key
    328f1593-2120-4a3b-b075-f20e9cb5b7c3

    Device Description

    Face Shield Attached w. AAMI IV Head Covering

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LYU Accessory, Surgical Apparel

    GMDN Terms

    Code Name
    11961 Face splash shield, single-use

    Identifiers

    Type ID
    Package 00854150007378
    Primary 00854150007361