BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lightbox Umbilical

    DI: 00851354004127 · Model: U100 · AVINGER, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lightbox Umbilical
    Primary DI
    00851354004127
    Version / Model
    U100
    Catalog Number
    U100
    Company Name
    AVINGER, INC.
    Labeler DUNS
    003152968
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-21
    Public Version
    1
    Public Version Date
    2019-03-29
    Public Version Status
    New
    Public Device Record Key
    e6c03753-3fc1-4d86-af3e-09840429266d

    Device Description

    Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PDU Catheter For Crossing Total Occlusions

    GMDN Terms

    Code Name
    59224 Mechanical atherectomy system generator, mechanical output

    Identifiers

    Type ID
    Primary 00851354004127