BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Penuma Penile Silicone Implant

    Reg #: 3010606546 · FEI: 3010606546 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INTERNATIONAL MEDICAL DEVICES, INC
    Registration Number
    3010606546
    FEI Number
    3010606546
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    717 N Maple Dr
    City
    Beverly Hills
    State
    CA
    ZIP
    90210
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220760

    Owner / Operator

    Firm Name
    International Medical Devices, Inc
    Operator Number
    10045461
    Address
    717 North Maple Drive
    City
    Beverly Hills
    State
    CA
    Postal Code
    90210
    Country
    US
    Correspondent
    James Elist

    Products

    Device Name Product Code
    Elastomer, Silicone Block MIB

    Proprietary Names

    Penuma Penile Silicone Implant Himplant Penile Silicone Implant

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility