BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Key Surgical, LLC

    Reg #: 2183785 · FEI: 2183785 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    48
    Establishment Types
    4
    Classifications
    27

    Registration Details

    Registration Name
    Key Surgical, LLC
    Registration Number
    2183785
    FEI Number
    2183785
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8101 Wallace Road
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160755

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10023158
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Utensil, Homemaking IKW
    Accessories, Cleaning Brushes, For Endoscope MNL
    Urinal FNP
    Wrap, Sterilization FRG
    Marker, Skin FZZ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Label Or Tag, Sterile LYV
    Container, Liquid Medication, Graduated KYW
    Clamp, Surgical, General & Plastic Surgery GDJ
    Anti Fog Solution And Accessories, Endoscopy OCT
    Screw, Fixation, Bone HWC
    Pin, Fixation, Smooth HTY
    Plate, Fixation, Bone HRS
    Endoscopic Bite Block MNK
    Needle, Suturing, Disposable GAB
    Clamp HXD
    Reamer HTO
    Tray, Surgical, Instrument FSM
    Orthopedic Manual Surgical Instrument LXH
    Tray, Surgical LRP
    Support, Patient Position CCX
    Bit, Drill HTW
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Basin, Emesis FNY
    Instrument, Surgical, Disposable KDC
    Indicator, Physical/Chemical Sterilization Process JOJ
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

    Solution Bucket/Pail Kick Bucket Endoscope Brush Pipe Cleaners Polypropylene Brushes Scope Cleaning Brushes Sterilization Wrap Skin Marker Sterile Labels BOWLS BASINS and PITCHERS MEDICINE CUP Tumbler Cautery Tip Cleaner Suture Booties, Silicone Clamp Covers Mr. Clear Electro Lube K-Wire and Steinmann Pin Endoscopic Bite Block Needle Counter Plastic Instruments Towel & Utility Clamp (KS385) Bone Reamer Brush Acetabular Brush K-Wire & Steinmann Pin Rack Sponge Bowl Instrument Trays Wash Basins K-Wire and Pin Cover Micro Mesh Trays Plastic Sterilization Trays Mesh Trays Corner Protector (KS-SD,RR) Hand Immobilizer Drill Bits Funnel Storage Container Beaker Dressing Jar Utility Scoop Measuring Pitcher Forceps Jar Ointment Jar Emesis Basin Vascular Loops Indicator Dot Case Locking Tags Indicator Dot Locking Tags K-Wire & Steinmann Pin Dispenser Instrument Organizers Instrument Stringer General Instruments

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device