BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioAccess1719 (WH) - NGD-1005A

    Reg #: 2183744 · FEI: 2183744 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    2183744
    FEI Number
    2183744
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    380 90TH AVE NW
    City
    Minneapolis
    State
    MN
    ZIP
    55433
    Country
    US

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Bur, Surgical, General & Plastic Surgery GFF

    Proprietary Names

    BioAccess1719 (WH) - NGD-1005A BioAccess1719 (WH) - NGD-1000 BioAccess1719 (WH) - High Torque Tool BioAccess1719 (WH) - Tool with Chuck BioAccess1719 (WH) - Small Bone Tool BioAccess1719 (WH) - Wire Chuck BioAccess1719 (WH) - Quick Release BioAccess1719 (WH) - Small Bone Tool with Collet BioAccess1719 (WH) - Keyless Chuck BioAccess1719 (WH) - Collet BioAccess1719 (WH) - WF-100 OmegaSurgical (LSRTC) - BUR, SURGICAL, GENERAL & PLASTIC SURGERY

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)