BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IRRAflow Laser Leveler Package

    DI: 00868643000463 · Model: ICLS 010 · Irras USA, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IRRAflow Laser Leveler Package
    Primary DI
    00868643000463
    Version / Model
    ICLS 010
    Catalog Number
    ICLS 010
    Company Name
    Irras USA, Inc.
    Labeler DUNS
    056999617
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-10
    Public Version
    1
    Public Version Date
    2024-06-18
    Public Version Status
    New
    Public Device Record Key
    f697a000-0952-45d3-8571-ddbee8a99b5f

    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
    MR Unsafe
    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
    JXG Shunt, Central Nervous System And Components

    GMDN Terms

    Code Name
    45552 Patient monitoring system module, intracranial pressure

    Identifiers

    Type ID
    Package 10868643000460
    Primary 00868643000463
    Package 20868643000467