BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    American Eagle Instruments

    DI: 00841013100000 · Model: AEMHRKIT · YOUNG DENTAL MANUFACTURING I, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    American Eagle Instruments
    Primary DI
    00841013100000
    Version / Model
    AEMHRKIT
    Company Name
    YOUNG DENTAL MANUFACTURING I, LLC
    Labeler DUNS
    006309355
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-03
    Public Version
    4
    Public Version Date
    2022-10-05
    Public Version Status
    Update
    Public Device Record Key
    53df4df1-ba69-469d-96e7-70a41af36fe0
    Distribution End Date
    2022-07-29

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EJB HANDLE, INSTRUMENT, DENTAL

    GMDN Terms

    Code Name
    64304 Manual non-rotary dental instrument handle

    Identifiers

    Type ID
    Primary 00841013100000