BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEINE LI-ION BATTERY

    DI: 00192896009592 · Model: X-007.99.676 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HEINE LI-ION BATTERY
    Primary DI
    00192896009592
    Version / Model
    X-007.99.676
    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
    45a4a6ae-5f39-4d38-a7a1-63da469ea5da

    Device Description

    HEINE LI-ION BATTERY FOR MPACK AND MPACK LL

    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

    Product Codes

    Code Name
    HLJ Ophthalmoscope, Battery-Powered

    GMDN Terms

    Code Name
    46790 Indirect binocular ophthalmoscope

    Identifiers

    Type ID
    Previous B099X007996760
    Primary 00192896009592

    Premarket Submissions

    Submission Number Supplement Number
    K142486 000