BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MRI Breast Coil Drape

    Reg #: 3005675811 · FEI: 3005675811 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    QSUM BIOPSY DISPOSABLES LLC
    Registration Number
    3005675811
    FEI Number
    3005675811
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8624 County Road 1 Sw
    City
    Pequot Lakes
    State
    MN
    ZIP
    56472
    Country
    US

    Regulatory Submissions

    510(k) Number
    K964142

    Owner / Operator

    Firm Name
    QSUM BIOPSY DISPOSABLES LLC
    Operator Number
    9085466
    Address
    8624 County Rd 1 SW, --
    City
    Pequot Lakes
    State
    MN
    Postal Code
    56472
    Country
    US
    Correspondent
    Kelsey - Bean

    Products

    Device Name Product Code
    Gown, Surgical FYA
    Drape, Surgical KKX

    Proprietary Names

    MRI Breast Coil Drape Lorad Stage Drape Interventional Drape Lorad Table Drape Fischer Stereotactic Table Drape MRI Breast Coil Headrest Drape Fischer AutoGuide Drape

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility