BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eli Ezer

    DI: 00851158007416 · Model: EZ-OTO-1800/HL · U.S. OPHTHALMIC, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eli Ezer
    Primary DI
    00851158007416
    Version / Model
    EZ-OTO-1800/HL
    Company Name
    U.S. OPHTHALMIC, L.L.C.
    Labeler DUNS
    166760392
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-28
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    0b428a87-805d-4c38-b27a-96df74c7c885

    Device Description

    Ophthalmoscope and Otoscope Diagnostic Set, 2 Pcs AA handle and Zipper Bag Halogen

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ERA Otoscope

    GMDN Terms

    Code Name
    60353 General physical examination set

    Identifiers

    Type ID
    Primary 00851158007416