BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARDINAL HEALTH

    DI: 10197106600368 · Model: SEN55OSNMC · Cardinal Health 200, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CARDINAL HEALTH
    Primary DI
    10197106600368
    Version / Model
    SEN55OSNMC
    Catalog Number
    SEN55OSNMC
    Company Name
    Cardinal Health 200, LLC
    Labeler DUNS
    961027315
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-10
    Public Version
    1
    Public Version Date
    2024-04-18
    Public Version Status
    New
    Public Device Record Key
    d9c021b2-6e74-49aa-bac5-c1facd4a793e

    Device Description

    ROQUE ORAL SURGERY PACK

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PWL Oral Surgery Tray

    GMDN Terms

    Code Name
    45148 Dental/maxillofacial surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 50197106600366
    Primary 10197106600368