BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Faxitron OR

    DI: 00857069006265 · Model: BioVision 10x15 · FAXITRON BIOPTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Faxitron OR
    Primary DI
    00857069006265
    Version / Model
    BioVision 10x15
    Company Name
    FAXITRON BIOPTICS, LLC
    Labeler DUNS
    968877360
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-02
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    1c1e3229-44b7-41f5-9232-e95c69e26454

    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
    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
    MWP Cabinet, X-Ray System

    GMDN Terms

    Code Name
    42280 Tissue specimen x-ray system IVD

    Identifiers

    Type ID
    Primary 00857069006265

    Premarket Submissions

    Submission Number Supplement Number
    K091558 000