BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STAR STERILE PACKAGED INSTRUMENTS 100-0071

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORCHID UNIQUE
    Registration Number
    1828288
    FEI Number
    1828288
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    ZIP
    48722
    Country
    US

    Regulatory Submissions

    PMA Number
    P050050

    Owner / Operator

    Firm Name
    Unique Instruments Inc.
    Operator Number
    10042005
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    Postal Code
    48722
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Ankle, Uncemented, Non-Constrained NTG

    Proprietary Names

    STAR STERILE PACKAGED INSTRUMENTS 100-0071 SS DRILL TIP WIRE 2.4 x 80mm 933-0018 DRILL TIP THREADED PIN W/SHOULDER 10mm 933-0026 ANTERIOR CHAMFER REAMER 925-0016 DRILL TIP THREADED PIN W/SHOULDER 15mm 933-0027 DRILL TIP THREADED PIN W/SHOULDER 20mm 933-0028 BARREL HOLE TWIST DRILL 905-0064 S.S. DRILL TIP WIRE 3.2mm x 150mm 454-0060

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)