BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Gantry Guard

    DI: 10687225488560 · Model: SCTG01 · PRECISION DYNAMICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    Gantry Guard
    Primary DI
    10687225488560
    Version / Model
    SCTG01
    Company Name
    PRECISION DYNAMICS CORPORATION
    Labeler DUNS
    008486367
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-07-28
    Public Version
    4
    Public Version Date
    2020-03-13
    Public Version Status
    Update
    Public Device Record Key
    bc28450f-3c4e-417d-a500-80fd2bef8b4e
    Distribution End Date
    2020-03-12

    Device Description

    Sample Pack - GANTRY GUARD™ CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 296 CM X 206 CM CLEAR, 3/pack

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PUI Drape, Surgical, Exempt

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Primary 10687225488560
    Unit of Use 80687225488569