BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SternaLock® XP Disposable Torque Driver

    DI: 10841291107293 · Model: 94-DRIVER-S · A & E MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SternaLock® XP Disposable Torque Driver
    Primary DI
    10841291107293
    Version / Model
    94-DRIVER-S
    Company Name
    A & E MEDICAL CORPORATION
    Labeler DUNS
    173770868
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-15
    Public Version
    1
    Public Version Date
    2022-12-23
    Public Version Status
    New
    Public Device Record Key
    d438fc49-f8ad-451e-b53a-d75134f5134d

    Device Description

    Disposable Torque Driver

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IKD Cable, Electrode

    GMDN Terms

    Code Name
    47143 Electrical-only medical device connection cable, single-use

    Identifiers

    Type ID
    Primary 10841291107293