BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Natus

    DI: 00382830058681 · Model: 60-000092 · XLTEK
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Natus
    Primary DI
    00382830058681
    Version / Model
    60-000092
    Company Name
    XLTEK
    Labeler DUNS
    245258280
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-22
    Public Version
    2
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    fea38c17-6ca3-414d-830b-963ec6ba74ad

    Device Description

    RetCam™ Envision Portrait Lens

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    HKI Camera, Ophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 00382830058681