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    FDA UDI In Commercial Distribution 🇺🇸 United States

    SeeLuma Digital Binoculars Module

    DI: 04064434000193 · Model: V12201-02 · Munich Surgical Imaging GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SeeLuma Digital Binoculars Module
    Primary DI
    04064434000193
    Version / Model
    V12201-02
    Company Name
    Munich Surgical Imaging GmbH
    Labeler DUNS
    315155571
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-05
    Public Version
    1
    Public Version Date
    2025-08-13
    Public Version Status
    New
    Public Device Record Key
    777add66-a5a3-447f-b702-6d028d94fef4

    Device Description

    SeeLuma Digital Binoculars Module is an accessory for the surgical microscope SeeLuma.

    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
    Yes
    Has Serial Number
    No
    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
    HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

    GMDN Terms

    Code Name
    64676 Ophthalmic surgical microscope

    Identifiers

    Type ID
    Primary 04064434000193