BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    K-Pack II Needle-21G x 2

    Reg #: 3008307705 · FEI: 3008307705 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Terumo Medical Canada, Inc.
    Registration Number
    3008307705
    FEI Number
    3008307705
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10911 Keele Street, Units 2-4
    City
    Vaughan Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K150263

    Owner / Operator

    Firm Name
    TERUMO MEDICAL CORP.
    Operator Number
    9003933
    Address
    265 Davidson Avenue, Ste. 320
    City
    Somerset
    State
    NJ
    Postal Code
    08873
    Country
    US

    US Agent

    Business Name
    Terumo Medical Corporation
    Contact Name
    Dina Justice
    Address
    950 Elkton Blvd
    City
    Elkton
    State
    MD
    ZIP
    21921
    Country
    US
    Email
    [email protected]
    Phone
    410 3927226

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    K-Pack II Needle-21G x 2

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device