BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Intelligent ICSI Micropipette

    DI: 00858604006061 · Model: IC.3.90.xx.B · HAMILTON THORNE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Intelligent ICSI Micropipette
    Primary DI
    00858604006061
    Version / Model
    IC.3.90.xx.B
    Company Name
    HAMILTON THORNE, INC.
    Labeler DUNS
    152161337
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-11
    Public Version
    1
    Public Version Date
    2024-12-19
    Public Version Status
    New
    Public Device Record Key
    6d810f05-c23e-4994-a50a-85706fa88c78

    Device Description

    Micropipette, ICSI, Feature Type 3, 90µm, 1.00mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PUC Microtools, Assisted Reproduction (Pipettes), Exempt

    GMDN Terms

    Code Name
    46553 Assisted reproduction microtool

    Identifiers

    Type ID
    Primary 00858604006061