BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    n/a

    DI: EJOT652104GTWR00100 · Model: GTWR.HP.100 · Jota AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    n/a
    Primary DI
    EJOT652104GTWR00100
    Version / Model
    GTWR.HP.100
    Company Name
    Jota AG
    Labeler DUNS
    480670983
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-15
    Public Version
    1
    Public Version Date
    2021-09-23
    Public Version Status
    New
    Public Device Record Key
    1a3df650-88ef-4998-9602-406aac2ec010
    Distribution End Date
    2021-09-15

    Device Description

    Burr, Orthopedic

    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
    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
    HTT Burr, Orthopedic

    GMDN Terms

    Code Name
    35170 Dental mandrel

    Identifiers

    Type ID
    Primary EJOT652104GTWR00100