BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PREFERRED MEDICAL PRODUCTS, LLC

    DI: 00680211002866 · Model: SC-100 · PREFERRED MEDICAL PRODUCTS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PREFERRED MEDICAL PRODUCTS, LLC
    Primary DI
    00680211002866
    Version / Model
    SC-100
    Catalog Number
    SC-100
    Company Name
    PREFERRED MEDICAL PRODUCTS, LLC
    Labeler DUNS
    161770292
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-05
    Public Version
    5
    Public Version Date
    2021-12-22
    Public Version Status
    Update
    Public Device Record Key
    4ee95a2e-7ab5-4239-8c8a-847f19f56563

    Device Description

    STERILE DISPOSABLE EQUIPMENT COVER - DOME COVER 50" DEPTH

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    47783 Patient surgical drape, single-use

    Identifiers

    Type ID
    Primary 00680211002866
    Package 10680211002863
    Package 40680211002864
    Package 50680211002861

    Premarket Submissions

    Submission Number Supplement Number
    K863853 000