BEUDAMED
    FDA Registration Active 🇺🇸 United States

    8.5F Dilator Sheath Set

    Reg #: 1724474 · FEI: 3003094851 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Terumo BCT STERILIZATION SERVICES, Inc.
    Registration Number
    1724474
    FEI Number
    3003094851
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11308 W Collins Ave
    City
    LAKEWOOD
    State
    CO
    ZIP
    80215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133631

    Owner / Operator

    Firm Name
    Terumo BCT, INC.
    Operator Number
    9002708
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80215
    Country
    US
    Correspondent
    Corrine Lucas

    Products

    Device Name Product Code
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    8.5F Dilator Sheath Set 13F Dilator Sheath Set 11.5F Dilator Sheath Set 11.5F Long Dilator Sheath Set 10F Dilator sheath Set 8.5F Long Dilator Sheath Set 10F Long Dilator Sheath Set 13F Long Dilator Sheath Set

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)