BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Vi-Radius

    DI: B293VR014300G0 · Model: VR014300G · MIVI NEUROVASCULAR
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vi-Radius
    Primary DI
    B293VR014300G0
    Version / Model
    VR014300G
    Company Name
    MIVI NEUROVASCULAR
    Labeler DUNS
    076836823
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-28
    Public Version
    4
    Public Version Date
    2019-02-11
    Public Version Status
    Update
    Public Device Record Key
    68c99ee6-0199-4742-a081-183832a46190
    Distribution End Date
    2019-02-08

    Device Description

    Vi-Radius Neuro Guidewire is a stainless steel wire core with a radiopaque platinum/ tungsten coil on the distal tip. The distal portion of the wire has a hydrophilic coating.

    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
    MR Unsafe
    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
    MOF Guide, Wire, Catheter, Neurovasculature
    DQX Wire, Guide, Catheter

    GMDN Terms

    Code Name
    35094 Cardiac/peripheral vascular guidewire, single-use

    Identifiers

    Type ID
    Primary B293VR014300G0

    Premarket Submissions

    Submission Number Supplement Number
    K151825 000

    Device Sizes

    Type Value Unit Text
    Length 300 Centimeter