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    FDA UDI In Commercial Distribution 🇺🇸 United States

    RetCam Envision

    DI: 05713315011924 · Model: 60-000070 · Natus Medical Denmark ApS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    RetCam Envision
    Primary DI
    05713315011924
    Version / Model
    60-000070
    Catalog Number
    60-000070
    Company Name
    Natus Medical Denmark ApS
    Labeler DUNS
    306633756
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-10
    Public Version
    1
    Public Version Date
    2026-02-18
    Public Version Status
    New
    Public Device Record Key
    672f1a18-a45e-47de-b755-66e03ac1c2cd

    Device Description

    Lens, 80 Degrees

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HKI Camera, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 05713315011924

    Premarket Submissions

    Submission Number Supplement Number
    K203500 000