BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Universal ACL Instrumentation

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    71
    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

    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
    Reamer HTO

    Proprietary Names

    Universal ACL Instrumentation ALPINE REAMER SIZE 13-14MM ALPINE REAMER SIZE 19-20MM ALPINE REAMER SIZE 9-10MM ALPINE REAMER SIZE 17-18MM EXTREMITY REAMER P/N 118-00004 EXTREMITY REAMER P/N 118-00005 EXTREMITY REAMER P/N 118-00006 RMR,SMALL BONE,,3,7mmx328mm (4020-037) RMR, ASSEMBLY, 5-FL, 21MM LONG RMR, ASEMBLY, 5-FL, 19.5MM LONG MRH REAMER ASSEMBLY, SIZE 3 MRH-RMR-03 ALPINE REAMER SIZE 11-12MM RMR, ASSEMBLY, 5-FL, 20MM LONG RMR,SMALL BONE,4.1MMX328MM (4020-041) EXTREMITY REAMER P/N 102-00011 RMR, ASSEMBLY, 5-FL, 24MM LONG REM, 23MM CUP REAMER #P04010A04 RMR, 5-FL, HUD, CANN, 10MM RMR,5-FL,HUD,CANN,13.5MM ALPINE REAMER SIZE 15-16MM RMR,4-FL,HUD,CANN,13MM RMR,5-FL,HUD,CANN,13MM RMR, HUDSON, (AR-9712PR) ARTHREX RMR,5-FL,HUD,CANN,12.5MM EXTREMETIY REAMER P/N 118-02015 RMR,5-FL,HUD,CANN,11MM RMR,SMALL BONE,3.1MMX328MM (4020-0310 RMR, ASSEMBLY, 5-FL, 23.5MM LONG Depuy Synthes Reamer Series 207, 211, 357, RMR,SMALL BONE, 5.1MMX328MM (4020-051) MRH PLANAR,ASSEMBLY MRH-PLN-00 RMR, ASSEMBLY, 5-FL, 22MM LONG REM, 23MM CONE REAMER #P04011A04 RMR, ASSEMBLY, 5-FL, 24.5MM LONG RMR, 5-FL, HUD, CANN, 13MM RMR, ASSEMBLY, 5-FL, 21.5MM LONG RMR,ASSEMBLY,5-FL,18.5MM LONG RMR,5-FL,HUD,CANN,12MM RMR,5-FL,HUD,CANN,10MM RMR, 4-FL, HUD, CANN, 13MM RMR, 5-FL, HUD, CANN, 13.5MM RMR, SMALL BONE, 3.7MM X 328MM RMR, 5-FL, HUD, CANN, 11MM RMR, ASSEMBLY,5-FL,19MM LONG RMR, 4-FL, HUD, CANN, 9 X 103MM RMR,5-FL,HUD,CANN,10.5MM RMR,4-FL,HUD,CANN,7X102MM RMR, 5-FL, HUD, CANN, 10.5MM RMR, 5-FL, HUD, CANN, 11.5MM FH ORTHOPEDICS COLLAR 4-FLUTE TAPERED REAMER #22657-0012 RMR, 5-FL, HUD, CANN, 12.5MM RMR, ASSEMBLY, 5-FL, 23MM LONG RMR, ASSEMBLY, 5-FL, 20.5MM LONG RMR, 5-FL, HUD, CANN, 12MM RMR,4-FL,HUD,CANN,9X103MM RMR, ASSEMBLY, 5-FL, 22.5MM LONG RMR, SMALL BONE, 3.1MM,X328MM RMR, 4-FL, HUD, CANN, 7 X 102MM RMR, SMALL BONE, 4.21MM X 328MM RMR, SMALL BONE, 5.1MM X 328MM RMR,5-FL,HUD,CANN,11.5MM PATHWAY IM DRILL 12MM PHALANGEAL REAMER, CONCAVE 8MM PHALANGEAL REAMER, CONCAVE 8MM PHALANGEAL REAMER, CONVEX 10MM PHALANGEAL REAMER, CONVEX 6MM PHALANGEAL REAMER, CONCAVE 12MM PHALANGEAL REAMER, CONVEX 10MM PHALANGEAL REAMER, CONCAVE 6MM PHALANGEAL REAMER, CONVEX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)