BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    American Eagle Instruments

    DI: 00841013105685 · Model: AEFH5-11 · 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
    00841013105685
    Version / Model
    AEFH5-11
    Company Name
    AMERICAN EAGLE INSTRUMENTS, INC.
    Labeler DUNS
    790776850
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-12
    Public Version
    3
    Public Version Date
    2022-10-05
    Public Version Status
    Update
    Public Device Record Key
    233af6d6-00d0-4515-89f7-1eabd3261785

    Device Description

    HIRSCHFELD 5-11 FILE (H1-5)

    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
    Dry Heat Sterilization

    Product Codes

    Code Name
    EKK SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

    GMDN Terms

    Code Name
    64078 Manual dental burnisher, reusable

    Identifiers

    Type ID
    Primary 00841013105685