BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UNIV. DRILL IRR TIP (MED/LONG

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    K040300

    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
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    UNIV. DRILL IRR TIP (MED/LONG CORE SAG SAW IRR. CLIP egg and shannon burs ELITE EX-LONG IRRIGATION CLIP CORE RECIP SAW IRR. CLIP ELITE MEDIUM IRRIGATION CLIP INT. IRR. NOZZLE 4cm STRAIGHT IRRIGATION CLIP TPS MICRO SAG SAW IRR. CLIP DURA GUARD IRRIGATION TIP 4cm ANGLED IRRIGATION CLIP QUANTUM DRILL IRRIGATION TIP TPS MICRO RECIP SAW IRR. CLIP DURA GUARD IRRIGATION CLIP TPS MICRO OSC SAW IRR. CLIP MICDRILL LONG ATTAC IRR. CLIP MICRODRILL ATTACH. IRR. CLIP ELITE LONG IRRIGATION CLIP CORE OSC SAW IRR. CLIP UNIV. DRILL IRR TIP (SHORT)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)