BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Interventional Systems

    DI: 00850015378911 · Model: 11718EU · EXACT MEDICAL MANUFACTURING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Interventional Systems
    Primary DI
    00850015378911
    Version / Model
    11718EU
    Catalog Number
    11718EU
    Company Name
    EXACT MEDICAL MANUFACTURING, INC.
    Labeler DUNS
    014464314
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-20
    Public Version
    2
    Public Version Date
    2023-11-01
    Public Version Status
    Update
    Public Device Record Key
    0031fe16-003c-4a9d-aa49-2d8148e38b93
    Distribution End Date
    2023-10-31

    Device Description

    Sterile Drape CCU 25cm wide x 100cm long

    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
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Package 00850015378928
    Primary 00850015378911
    Package 00850015378935