BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Personalized PseudoPatient™ PV

    DI: 00860001523218 · Model: PFL-02PV · RTSAFE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Personalized PseudoPatient™ PV
    Primary DI
    00860001523218
    Version / Model
    PFL-02PV
    Catalog Number
    PFL-02PV
    Company Name
    RTSAFE, INC.
    Labeler DUNS
    080928779
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-31
    Public Version
    2
    Public Version Date
    2019-11-27
    Public Version Status
    Update
    Public Device Record Key
    8fe98bd2-848c-4f95-ac21-152a9e87efbc

    Device Description

    Personalized PseudoPatient™ PV FL

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYE Accelerator, Linear, Medical

    GMDN Terms

    Code Name
    62215 Custom-made organ/bone anatomy model

    Identifiers

    Type ID
    Primary 00860001523218

    Customer Contacts

    Phone
    210-542-5822
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180697 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    20 – 24 Degrees Celsius