BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Puritan Fecal Opti-swab Collection and Transport System

    Reg #: 3010131578 · FEI: 3010131578 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Gamma Centre of Excellence
    Registration Number
    3010131578
    FEI Number
    3010131578
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    535 Cartier Boulevard Ouest
    City
    Laval Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K162284

    Owner / Operator

    Firm Name
    Nordion Canada Inc.
    Operator Number
    8022247
    Address
    447 MARCH RD., --
    City
    OTTAWA
    State
    Ontario
    Postal Code
    K2K1X8
    Country
    CA
    Correspondent
    Natalie - Girard

    US Agent

    Business Name
    Sterigenics
    Contact Name
    Chris Eustace
    Address
    2015 Spring Rd Ste 650
    City
    Oak Brook
    State
    IL
    ZIP
    60523
    Country
    US
    Email
    [email protected]
    Phone
    630 9281700

    Products

    Device Name Product Code
    Device, Specimen Collection LIO
    System, Transport, Aerobic JTW
    Culture Media, Non-Propagating Transport JSM
    Transport Systems, Anaerobic JTX

    Proprietary Names

    Puritan Fecal Opti-swab Collection and Transport System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)