BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ORI

    DI: 06975085708643 · Model: SF-3LB · Operating Room Innovations, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ORI
    Primary DI
    06975085708643
    Version / Model
    SF-3LB
    Catalog Number
    SF-3LB
    Company Name
    Operating Room Innovations, Inc.
    Labeler DUNS
    080246656
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-03
    Public Version
    3
    Public Version Date
    2025-07-11
    Public Version Status
    Update
    Public Device Record Key
    4d99a5be-0675-432b-ad7e-65b320fff65a
    Distribution End Date
    2025-06-13

    Device Description

    Solofit AAMI III SMS Gown Large

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    No
    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
    FYA Gown, Surgical

    GMDN Terms

    Code Name
    35091 Surgical gown, single-use

    Identifiers

    Type ID
    Package 26975085708647
    Primary 06975085708643