BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surgical Instrument

    DI: 08800298539297 · Model: 475AD · OSTEONIC CO.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Surgical Instrument
    Primary DI
    08800298539297
    Version / Model
    475AD
    Company Name
    OSTEONIC CO.,Ltd.
    Labeler DUNS
    688999370
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-06
    Public Version
    2
    Public Version Date
    2025-03-18
    Public Version Status
    Update
    Public Device Record Key
    3d915992-75f4-4797-92e4-5c2717d891da

    Device Description

    4.75 Bone Awl (Disposable)

    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
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HWJ Awl

    GMDN Terms

    Code Name
    66274 Bone awl, single-use

    Identifiers

    Type ID
    Primary 08800298539297