BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BONE FILE #21 SINGLE CUT H/O D/E

    DI: D928105221HO0 · Model: 10-5221H/O · W.H. Holden, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BONE FILE #21 SINGLE CUT H/O D/E
    Primary DI
    D928105221HO0
    Version / Model
    10-5221H/O
    Company Name
    W.H. Holden, Inc.
    Labeler DUNS
    183854322
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-10
    Public Version
    1
    Public Version Date
    2023-10-18
    Public Version Status
    New
    Public Device Record Key
    f0c031e1-223c-4846-a828-777115dccba9

    Device Characteristics

    Single Use
    No
    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EMI FILE, BONE, SURGICAL

    GMDN Terms

    Code Name
    64007 Bone file/rasp, reciprocating, single-use

    Identifiers

    Type ID
    Primary D928105221HO0