BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Scope HelpOR

    DI: 09349967003206 · Model: SHK-01 · THE O R COMPANY PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Scope HelpOR
    Primary DI
    09349967003206
    Version / Model
    SHK-01
    Company Name
    THE O R COMPANY PTY LTD
    Labeler DUNS
    744346235
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-27
    Public Version
    2
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    48512f32-3179-4c8e-8ea4-567fb7a101df

    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
    No
    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
    NWV Laparoscopic Accessories, Gynecologic

    GMDN Terms

    Code Name
    36816 Instrument warmer, electric

    Identifiers

    Type ID
    Package 09349967003220
    Package 09349967003213
    Primary 09349967003206