BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Drill Bit 4.5mm AO Shank Depth Control 0-60 mm for Drill Guide

    DI: 04056481145842 · Model: 41839-39 · Brainlab SE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Drill Bit 4.5mm AO Shank Depth Control 0-60 mm for Drill Guide
    Primary DI
    04056481145842
    Version / Model
    41839-39
    Company Name
    Brainlab SE
    Labeler DUNS
    314482980
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-22
    Public Version
    3
    Public Version Date
    2025-10-06
    Public Version Status
    Update
    Public Device Record Key
    0f5eeb4a-d090-4247-8d50-1b125957fac3

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    No
    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
    OLO Orthopedic Stereotaxic Instrument

    GMDN Terms

    Code Name
    32390 Fluted surgical drill bit, reusable

    Identifiers

    Type ID
    Primary 04056481145842

    Premarket Submissions

    Submission Number Supplement Number
    K221618 000
    K240701 000
    K252562 000