BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ST RND BUR CARBIDE 6.5MM

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1058584
    FEI Number
    1000219637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10811 Withers Cove Park Drive
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K781979

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ

    Proprietary Names

    ST RND BUR CARBIDE 6.5MM ST BUR HVY GRIT DIAM. 5MM ST UPWR BUR STRT 9X9MM/MDS M-4 ST ULTRAPOWER BUR RND 1.5MM ST ULTRAPOWER BUR CUTTER 13.5MM ST ULTRAPOWER BUR STRT 10.5X11 RX-1 ST RND BUR CARBIDE 3MM ST ULTRAPOWER BUR RND 0.7MM ST ULTRAPOWER BUR CUTTER 10.7MM ST BUR HVY GRIT DIAM. 4MM ST RND BUR CARBIDE .5MM 5EA ST UPWR BUR STRT 5X17/MDS M-9 ULTRAPOWER BUR, TAPERED (MUSTARD), 1.5MM X 8MM ST UPWR BUR ACORN 7.5/MDS-RX2 ST BUR HVY GRIT DIAM. 3MM ST ULTRAPOWER BUR ACORN 7.5MM ST UPWR BUR STRT 6X8MM/MDS-M-1 ST UP BUR TREPHINE 13.5MM ST ULTRAPOWER BUR CUTTER 16.8MM ST UPWR DPTH LMT DRILL 1.3X80MM ST ULTRAPOWER BUR RND DMDCRS 1MM ST ULTRAPOWER BUR RND DMD7MM ST ROUND BUR CARBIDE 1MM ST ULTRAPOWER BUR RTRPD 2.2MM X 23MM ST RND BUR .5MM ST BUR HVY GRIT DIAM. 6MM ST BUR HVY GRIT DIAM. 6MM 5EA

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)