BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Epredia

    DI: 05051663010252 · Model: NX50 CRYOSTAR OPH · SHANDON DIAGNOSTICS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Epredia
    Primary DI
    05051663010252
    Version / Model
    NX50 CRYOSTAR OPH
    Company Name
    SHANDON DIAGNOSTICS LIMITED
    Labeler DUNS
    219103512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-15
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    540e947a-c716-46ac-a8a9-391af63c28d4

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    IDP Microtome, Cryostat

    GMDN Terms

    Code Name
    15157 Cryostat microtome IVD

    Identifiers

    Type ID
    Primary 05051663010252