BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OmniBone Bone Biopsy Kit with 11 Gauge 68mm length

    DI: 00810563022728 · Model: OMB11/6.5 · Varian Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    OmniBone Bone Biopsy Kit with 11 Gauge 68mm length
    Primary DI
    00810563022728
    Version / Model
    OMB11/6.5
    Company Name
    Varian Medical Systems, Inc.
    Labeler DUNS
    118097024
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-18
    Public Version
    2
    Public Version Date
    2025-10-06
    Public Version Status
    Update
    Public Device Record Key
    611f0981-fc20-4e8b-9de4-9178ab292fd7

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    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
    KNW Instrument, biopsy

    GMDN Terms

    Code Name
    60477 Bone biopsy needle

    Identifiers

    Type ID
    Package 10810563022725
    Primary 00810563022728

    Premarket Submissions

    Submission Number Supplement Number
    K230015 000