BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Punctur-Guard

    Reg #: 8020347 · FEI: 3005612924 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NIPRO CANADA CORPORATION
    Registration Number
    8020347
    FEI Number
    3005612924
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    199 ST. DAVID STREET
    City
    LINDSAY Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K963748

    Owner / Operator

    Firm Name
    NIPRO CANADA CORPORATION
    Operator Number
    8020347
    Address
    199 St. David Street, --
    City
    LINDSAY
    State
    Ontario
    Postal Code
    K9V 5K7
    Country
    CA
    Correspondent
    Raphael C DUBE

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Punctur-Guard

    Establishment Types

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