BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    American Eagle Instruments

    DI: 00841013112829 · Model: AEUS25-10 · AMERICAN EAGLE INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    American Eagle Instruments
    Primary DI
    00841013112829
    Version / Model
    AEUS25-10
    Company Name
    AMERICAN EAGLE INSTRUMENTS, INC.
    Labeler DUNS
    790776850
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    6
    Public Version Date
    2022-10-05
    Public Version Status
    Update
    Public Device Record Key
    1124a6be-1ee3-4ac1-a5d4-48c7635e7789
    Distribution End Date
    2022-07-28

    Device Description

    MAGNETOSTRICTIVE #10-25K RED

    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
    No
    PM Exempt
    No
    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", "Dry Heat Sterilization"]

    Product Codes

    Code Name
    ELC Scaler, Ultrasonic

    GMDN Terms

    Code Name
    44908 Ultrasonic dental scaling/debridement system handpiece tip, periodontal

    Identifiers

    Type ID
    Primary 00841013112829