BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    D-SPECT®

    DI: 07290108670004 · Model: 003 · SPECTRUM DYNAMICS MEDICAL, INC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    D-SPECT®
    Primary DI
    07290108670004
    Version / Model
    003
    Catalog Number
    8010029-01
    Company Name
    SPECTRUM DYNAMICS MEDICAL, INC
    Labeler DUNS
    078864620
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    4
    Public Version Date
    2022-12-12
    Public Version Status
    Update
    Public Device Record Key
    720f4efa-6bf5-4322-8f26-655c1ef583de
    Distribution End Date
    2022-12-11

    Device Description

    Single-photon emission computed tomography system

    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
    Labeling does not contain MRI Safety Information
    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
    LLZ System, Image Processing, Radiological
    KPS System, Tomography, Computed, Emission

    GMDN Terms

    Code Name
    40643 SPECT system, annular detector array

    Identifiers

    Type ID
    Primary 07290108670004