BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Key Surgical Drill Bits

    DI: 00849771026396 · Model: KI-86-8415 · KEY SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Key Surgical Drill Bits
    Primary DI
    00849771026396
    Version / Model
    KI-86-8415
    Company Name
    KEY SURGICAL, INC.
    Labeler DUNS
    604056226
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-21
    Public Version
    4
    Public Version Date
    2023-01-24
    Public Version Status
    Update
    Public Device Record Key
    e2cb90f0-03c2-459e-a144-a6af81425ba6
    Distribution End Date
    2023-01-18

    Device Description

    Twist Drill Bit, 5-inch str shank double fluted, 1.5mm diameter, 17mm, round end

    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
    No
    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
    HTW Bit, Drill

    GMDN Terms

    Code Name
    32390 Fluted surgical drill bit, reusable

    Identifiers

    Type ID
    Primary 00849771026396

    Customer Contacts

    Phone
    +1(800)541-7995
    Email
    [email protected]