BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UltraSPECT

    DI: 00850040177121 · Model: 4.38.3.3 · Ultraspect Usa, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UltraSPECT
    Primary DI
    00850040177121
    Version / Model
    4.38.3.3
    Company Name
    Ultraspect Usa, LLC
    Labeler DUNS
    118594942
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-20
    Public Version
    1
    Public Version Date
    2022-05-30
    Public Version Status
    New
    Public Device Record Key
    23e4665a-7d82-44cd-a797-3a1a241bf9ce

    Device Description

    WBR Imaging X + X3 + Bone/Xact + ACSC

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LLZ System, Image Processing, Radiological
    KPS System, Tomography, Computed, Emission

    GMDN Terms

    Code Name
    40869 SPECT system application software

    Identifiers

    Type ID
    Primary 00850040177121

    Premarket Submissions

    Submission Number Supplement Number
    K080784 000
    K081201 000
    K091073 000