BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hemostasis Adapter

    DI: M58800100111411 · Model: IV-1 · STEREOTAXIS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    Hemostasis Adapter
    Primary DI
    M58800100111411
    Version / Model
    IV-1
    Catalog Number
    0010011141
    Company Name
    STEREOTAXIS, INC.
    Labeler DUNS
    024942265
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2021-12-14
    Public Version
    1
    Public Version Date
    2021-12-22
    Public Version Status
    New
    Public Device Record Key
    3d740963-7fcc-45b4-ab4b-9388c355907d

    Device Description

    Hemostasis Adapter IV Spares, Box, Device Count(5)

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQX Wire, Guide, Catheter

    GMDN Terms

    Code Name
    31742 Cardiac mapping system workstation

    Identifiers

    Type ID
    Unit of Use M58800100111410
    Primary M58800100111411

    Premarket Submissions

    Submission Number Supplement Number
    K071029 000