BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GM501 Gradient 45%

    Reg #: 1221433 · FEI: 1221433 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HAMILTON THORNE, Inc.
    Registration Number
    1221433
    FEI Number
    1221433
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    100 CUMMINGS CENTER-SUITE 465E
    City
    Beverly
    State
    MA
    ZIP
    01915
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053494

    Owner / Operator

    Firm Name
    Hamilton Thorne, Inc.
    Operator Number
    1221433
    Address
    100 Cummings Center, Suite 465E
    City
    Beverly
    State
    MA
    Postal Code
    01915
    Country
    US
    Correspondent
    Nicole M Thibodeau

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    GM501 Gradient 45% GM501 SpermStore GM501 Gradient 90% GM501 Gradient 100%

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198