BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEINE MPACK UNPLUGGED BATTERY

    DI: 00192896009554 · Model: X-007.99.666 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HEINE MPACK UNPLUGGED BATTERY
    Primary DI
    00192896009554
    Version / Model
    X-007.99.666
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-24
    Public Version
    2
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    22291132-c2fd-48ae-8d4a-e103ec161033

    Device Description

    HEINE MPACK UNPLUGGED BATTERY WITH MOBILE TRANSFORMER

    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
    No
    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", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    HLJ Ophthalmoscope, Battery-Powered

    GMDN Terms

    Code Name
    46790 Indirect binocular ophthalmoscope

    Identifiers

    Type ID
    Previous B099X007996660
    Primary 00192896009554

    Customer Contacts

    Phone
    8008217496
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K142486 000