BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioAccess1719 (WH) - NGD-1005A

    Reg #: 2245304 · FEI: 2245304 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    2245304
    FEI Number
    2245304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Apollo Dr
    City
    WHIPPANY
    State
    NJ
    ZIP
    07981
    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)