BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Smith&Nephew3754 (NR) - BIOSURE™ PK, 10 mm x 25 mm

    Reg #: 1220477 · FEI: 1220477 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1220477
    FEI Number
    1220477
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    435 WHITNEY ST.
    City
    Northboro
    State
    MA
    ZIP
    01532
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083635

    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
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Smith&Nephew3754 (NR) - BIOSURE™ PK, 10 mm x 25 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 8 mm x 25 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 10 mm x 30 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 7 mm x 20 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 9 mm x 25 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 10 mm x 20 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 12 mm x 35 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 11 mm x 35 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 8 mm x 35 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 6 mm x 25 mm, Reverse Smith&Nephew3754 (NR) - BIOSURE™ PK, 7 mm x 30 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 9 mm x 30 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 6 mm x 20 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 8 mm x 20 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 8 mm x 30 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 11 mm x 25 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 9 mm x 20 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 7 mm x 25 mm, Reverse Smith&Nephew3754 (NR) - BIOSURE™ PK, 8 mm x 25 mm, Reverse Smith&Nephew3754 (NR) - BIOSURE™ PK, 9 mm x 35 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 10 mm x 35 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 11 mm x 30 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 7 mm x 25 mm Smith&Nephew3754 (NR) - BIOSURE™ PK, 6 mm x 25 mm

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)