BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TruClear Dense Tissue Shaver Plus, TruClear Soft Tissue Shaver Mini, TruClear Soft Tissue Shaver Plus

    Reg #: 1222313 · FEI: 1000121050 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PROFESSIONAL CONTRACT STERILIZATION, INC.
    Registration Number
    1222313
    FEI Number
    1000121050
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    40 Myles Standish Blvd
    City
    Taunton
    State
    MA
    ZIP
    02780
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161763

    Owner / Operator

    Firm Name
    Professional Contract Sterilization, Inc.
    Operator Number
    10043067
    Address
    40 Myles Standish Blvd
    City
    Taunton
    State
    MA
    Postal Code
    02780
    Country
    US
    Correspondent
    Gary Cranston

    Products

    Device Name Product Code
    Hysteroscope (And Accessories) HIH

    Proprietary Names

    TruClear Dense Tissue Shaver Plus, TruClear Soft Tissue Shaver Mini, TruClear Soft Tissue Shaver Plus

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)