BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    MP2040S MOLLI OncoPen Elite

    Reg #: 3015439135 · FEI: 3015439135 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MOLLI SURGICAL INC.
    Registration Number
    3015439135
    FEI Number
    3015439135
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 Wellington Street East, Suite 400
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K234149

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    US Agent

    Business Name
    Stryker Endoscopy
    Contact Name
    April Malmborg
    Address
    5900 Optical Ct.
    City
    San Jose
    State
    CA
    ZIP
    95138
    Country
    US
    Email
    [email protected]
    Phone
    408 4093115

    Products

    Device Name Product Code
    Marker, Radiographic, Implantable NEU

    Proprietary Names

    MP2040S MOLLI OncoPen Elite MP2025S MOLLI OncoPen Prime MT2001 MOLLI 2 Tablet MP2015A MOLLI OncoPen

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device