BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    PINPOINT System

    Reg #: 3012345110 · FEI: 3012345110 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Novadaq Technologies ULC
    Registration Number
    3012345110
    FEI Number
    3012345110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8329 Eastlake Drive, Unit 101
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K182606

    Owner / Operator

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

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    PINPOINT System PP9037 PINPOINT Kit SPY-MIS Kit SPY-MIS Pack PP9036 PINPOINT Endoscopic Fluorescence Imaging System PINPOINT Lymphatics Kit PINPOINT Pack PINPOINT Lymphatics Pack Pinpoint Light Cable Pinpoint Camera Head Pinpoint Laparoscope - 10mm, Standard, 30 with Wolf and Storz adaptor Pinpoint Laparoscope - 10mm, Standard, 45 with Wolf and Storz adaptor Pinpoint Laparoscope - 5mm, Standard, 45 with Wolf and Storz adaptor Pinpoint Laparoscope - 5mm, Standard, 30 with Wolf and Storz adaptor Pinpoint Laparoscope - 5mm, Standard, 0 with Wolf and Storz adaptor Pinpoint Laparoscope - 10mm, Standard, 0 with Wolf and Storz adaptor Video Processor/Illuminator (VPI)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198