BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Standard Imaging Reconstruction Jig Large

    DI: 00850019946567 · Model: 91280 · STANDARD IMAGING INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Standard Imaging Reconstruction Jig Large
    Primary DI
    00850019946567
    Version / Model
    91280
    Catalog Number
    91280
    Company Name
    STANDARD IMAGING INC.
    Labeler DUNS
    788084705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-22
    Public Version
    1
    Public Version Date
    2023-06-30
    Public Version Status
    New
    Public Device Record Key
    65654e6b-ee5a-40bf-a0a2-d0b67d1c7712

    Device Description

    Standard Imaging Reconstruction Jig Large allows spatial localization of catheters or other setups for HDR brachytherapy applications. It allows determination of the position of objects in space to a high degree of accuracy.

    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
    Yes
    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
    IXG Phantom, Anthropomorphic, Radiographic

    GMDN Terms

    Code Name
    40631 Multi-modality therapeutic radiation phantom, test object

    Identifiers

    Type ID
    Primary 00850019946567