BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mini Cradle - US

    DI: 17290109154197 · Model: 15042-000-0010 · EITAN MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mini Cradle - US
    Primary DI
    17290109154197
    Version / Model
    15042-000-0010
    Catalog Number
    15042-000-0010
    Company Name
    EITAN MEDICAL LTD
    Labeler DUNS
    533108028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-15
    Public Version
    2
    Public Version Date
    2022-11-23
    Public Version Status
    Update
    Public Device Record Key
    0f5bbeae-9fce-451d-9d85-e1262d079e50

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MRZ Accessories, Pump, Infusion

    GMDN Terms

    Code Name
    61952 Frame/rail/pole device holder

    Identifiers

    Type ID
    Package 27290109154194
    Primary 17290109154197
    Direct Marking 07290109154190

    Customer Contacts

    Phone
    949.288.5482
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K192860 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -40 – 70 Degrees Celsius