BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    1150 - Lumen tray only

    DI: 00816634020204 · Model: 1150 · Ultra Clean Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    1150 - Lumen tray only
    Primary DI
    00816634020204
    Version / Model
    1150
    Company Name
    Ultra Clean Systems, Inc.
    Labeler DUNS
    010043227
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-13
    Public Version
    3
    Public Version Date
    2025-05-15
    Public Version Status
    Update
    Public Device Record Key
    e40eb8ad-b7d1-47a8-b518-2a53f78c8795

    Device Description

    Model 1150 - Lumen tray only

    Device Characteristics

    Single Use
    No
    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
    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
    FLG Cleaner, Ultrasonic, Medical Instrument

    GMDN Terms

    Code Name
    36749 Ultrasonic-cleaning water bath

    Identifiers

    Type ID
    Primary 00816634020204
    Package 10816634020201
    Package 10816634020140