BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SEISMIQ™

    DI: 00850056723084 · Model: FG-010978 · Bolt Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SEISMIQ™
    Primary DI
    00850056723084
    Version / Model
    FG-010978
    Catalog Number
    FG-010978
    Company Name
    Bolt Medical, Inc.
    Labeler DUNS
    117202600
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-27
    Public Version
    1
    Public Version Date
    2025-12-05
    Public Version Status
    New
    Public Device Record Key
    4796f455-30c6-4f72-8a9d-8401fe538cf5

    Device Description

    Intravascular Lithotripsy Console

    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
    MR Unsafe
    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
    PPN Percutaneous Catheter, Ultrasound

    GMDN Terms

    Code Name
    66730 Intravascular lithotripsy system generator

    Identifiers

    Type ID
    Primary 00850056723084