BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Needle Hub Assembly for Invivo Breast Biopsy Pillar System

    Reg #: 3009656988 · FEI: 3009656988 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERIPACK USA (LIMITED) LLC
    Registration Number
    3009656988
    FEI Number
    3009656988
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4255 S Pipkin Rd
    City
    Lakeland
    State
    FL
    ZIP
    33811
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032576

    Owner / Operator

    Firm Name
    SteriPack USA (Limited) LLC
    Operator Number
    10044297
    Address
    4255 South Pipkin Road
    City
    Lakeland
    State
    FL
    Postal Code
    33811
    Country
    US
    Correspondent
    Marinela Cebic

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    Needle Hub Assembly for Invivo Breast Biopsy Pillar System Grid Immobilization Plate LBS M-L for Invivo Breast Biopsy System LBS Grid Immobilization Plate BBC for Invivo Breast Biopsy Coil Fiducial Holder for Invivo BBC Mammotome Device Pillar Immobilization Plate BBC for Invivo Breast Biopsy Coil Pillar Immobilization Plate BBC for Invivio Mammotome Device Pillar Immobilization Plate LBS C-C for Invivo Breats Biopsy System LBS Grid Immobilization Plate LBS C-C for Invivo Breast Biopsy System LBS Pillar Immobilization Plate LBS M-L for Invivo Biopsy System LBS Needle Block Holder for Invivo Breast Biopsy Grid System Pillar Immobilization Plate for Invivo LBS Mammotome Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)