BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Cover

    DI: 00848340020117 · Model: 08-CC141 · ADVANCE MEDICAL DESIGNS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Custom Cover
    Primary DI
    00848340020117
    Version / Model
    08-CC141
    Company Name
    ADVANCE MEDICAL DESIGNS, INC.
    Labeler DUNS
    130785884
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-08
    Public Version
    1
    Public Version Date
    2024-02-16
    Public Version Status
    New
    Public Device Record Key
    c2825ca6-02a8-4d35-9c0a-db8faf812d09

    Device Description

    Disposable Equipment Cover

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    JAA System, x-ray, fluoroscopic, image-intensified

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Package 10848340020114
    Primary 00848340020117

    Premarket Submissions

    Submission Number Supplement Number
    K850959 000