BEUDAMED
    FDA Registration Active 🇺🇸 United States

    5820512310 1MM TAPERED ROUND DIAMOND

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    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

    510(k) Number
    K143320

    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
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Proprietary Names

    5820512310 1MM TAPERED ROUND DIAMOND 5820566232 CROSS CUT FIS. BUR, EXT 3.2mm 5820601021 SHANNON SIDE CUT DRILL(2.1MM) 5820512005S2 ROUND DIAMOND BUR, MED 0.5MM 5820517160 BARREL BUR SOFT TOUCH (6MM) 5820280021 ELITE HELICOIDAL RASP BLANK 5820512305 0.5MM TAPERED ROUND DIAMOND 5820507080 HALF RND DIA BUR CRSE 8MM 5820520030 FLUTED DRUM BUR(3mmX5mm) 5820507070 HALF RND DIA BUR CRSE 7MM 5820520040S1 X-COARSE DRUM BUR(4MMX7MM) 5820512330 3MM TAPERED ROUND DIAMOND 5820513320 2MM TAPERED RND DIA CRSE ELITE 5820520050 FLUTED DRUM BUR(5mmX7mm) 5820512340 4MM TPRD RND DIA ELITE BUR 5820513145S1 RND DIA BUR XX COARSE 4.5MM 5820566016 1.6MM CROSS CUT FISSURE BUR 5820512315 1.5MM TAPERED ROUND DIAMOND 5820566221 2.1MM CROSS CUT FIS. BUR, EXT 5820512325 2.5MM TAPERED ROUND DIAMOND 5820510305 0.5MM TAPERED ROUND ELITE BUR 5820566216 1.6MM CROSS CUT FIS. BUR, EXT 5820601030 SHANNON SIDE CUT DRILL(3MM) 5820512010S2 5820-12-10 W/ELITE SHANK 5820512320 2MM TAPERED ROUND DIAMOND 5820522092 DIA DRUM MILLING BUR9.2X10.4MM 5820520040 FLUTED DRUM BUR(4mmX6mm) 5820512040S2 ROUND DIAMOND BUR SHORT 4mm 5820566010 1MM CROSS CUT FISSURE BUR 5820608035 DRILL BIT W/8MM STOP (3.5MM) 5820601025 SHANNON SIDE CUT DRILL(2.5MM) 5820566012 1.2MM CROSS CUT FISSURE BUR 5820520045 FLUTED DRUM BUR(4.5mmX7mm) 5820566021 2.1MM CROSS CUT FISSURE BUR 5820520035 FLUTED DRUM BUR(3.5mmX5.5mm)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)