BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bur Guard Sleeve MicroChoice 30/BX

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    57
    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

    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
    Motor, Surgical Instrument, Pneumatic Powered GET

    Proprietary Names

    Bur Guard Sleeve MicroChoice 30/BX Bur Guard Sleeve Surgairtome II 30/BX STRYKER 2000 SAGITTAL BLADE REPLACEMENT 24.82 X 73.79 X 0.89MM (35 INCH) INTREX LARGE BONE OSCILLATING SAW BLADE 25 X 9 X 90 X 17MM, 5EA STRYKER SAGITTAL BLADE REPLACEMENT 25MM X 98.5MM X 1.24MM ST ULTRAPOWER BUR STRT 10.5X11 R14 ST UPWR BUR STRT 7.5X9/MDS-R5 ST UPWR BUR STRT 9X9MM/MDS-0-4 ST ULTRAPOWER BUR RND 1MM ST BRZL OSC BLADE 19.5X80X.8MM 5 EA ST ULTRAPOWER BUR STRT HD 5 X 8MM ST UPWR BUR STRT 7.5X28MDSAM15 STRYKER 2000 SAGITTAL BLADE REPLACEMENT 9.12 X 25.22 X 0.64MM (25 IN) STRYKER 2000 SAGITTAL BLADE REPLACEMENT 25.4 X 90 X 0.8MM (31 INCH) ST UPWR BUR STRT 9X5/MDS 0-6 10 X 3 X 0.4MM MICRO OSCILLATOR BLADE, ANGLED, EXTENDED, QTY 5 GRAFT HARVESTING BLADE 13 X 20MM INTREX LARGE BONE OSCILLATING SAW BLADE 25 X 9 X 90 X 0.89MM, 5EA ST UPWR BUR STRT 7.5X9/MDS-AM5 ST UPWR BUR STRT 6X8/MDS AM11 3MM ULTRAPOWER BUR, ROUND (COPPER) ST BRZL RIB OSC BLD 19.5X80X.9MM 5 EA 6.5 X 30 X 0.6MM SAGITTAL/OSCILLATOR BLADE 5 EA STRYKER 2000 SAGITTAL BLADE REPLACEMENT 28.91 X 84.47 X 1.27MM (50INCH) ST UPWR BUR BARREL 10MM AM23 GRAFT HARVESTING BLADE 12 X 20MM 2.2MM X 23MM ULTRAPOWER BUR, TAPERED (COPPER) ST UPWR BUR STRT 7.5X9/MDS-RX5 ST UPWR BUR DMD RND/CYL 1.9MM INTREX LARGE BONE OSCILLATING SAW BLADE 13 X 8 X 70 X 1.37MM, 5 EA ST UPWR BUR STRT 7.5X9/MDS 0-5 STRYKER 2000 SAGITTAL BLADE REPLACEMENT 24.82 X 82.42 X 1.37MM (54 IN) OSCILLATING SAW BLADE 19MM X 1.35MM (053 IN) X 105MM, QTY 5 25.4 X 95 X 1, 1MM LARGE BONE HALL BLADE, OSCILLATING, QTY 5 INTREX LARGE BONE OSCILLATING SAW BLADE 25 X 90 X 10MM, 1 EA ST UPWR BUR BARREL 5X8MDS TU12 19 X 71MM 3M MAXI-DRIVER OSCILLATOR BLADE REPLACEMENT, 5 EA SMARTGUARD MICRO 100, QTY 30 ST UPWR BUR STRT 5X8/MDS-0-12 MICRO SAGITTAL SAW BLADE 14 X 41 MM ULTRAPOWER BUR, ROUND (TEAL), 8MM 16.5 X 95 X 1.27 LARGE BONE, HALL BLADE, OSCILLATING, QTY 5 GRAFT HARVESTING BLADE 5 X 20MM INTREX LARGE BONE OSCILLATING SAW BLADE 13 X 8 X 70 X 17MM, 5 EA ST ULTRAPOWER BUR RND 0.7MM ST ULTRAPOWER BUR RND DMD CRS 2MM MICRO PILOT DRILL, SHORT 1.5 X 20MM ST UPWR BUR TPRD 1.5X8MM ST UPWR BUR STRT 3X20/MDS-RX13 OSCBLD 25.4 X 90 X 1.27 STRYKER 2000 SAGITTAL BLADE REPLACEMENT 24.82 X 80.14 X 1.50MM (60 IN) STRYKER 2000 SAGITTAL BLADE REPLACEMENT 29.46 X 58.7 X 0.64MM (0.25 INCH) DIAMOND BUR, HEAVY GRIT, 2MM, QTY 5 SMARTGUARD MICROCHOICE, QTY 30 MICROBUR SIDECUT 67MML STERILE 5EA STRYKER 2000 SAGITTAL BLADE REPLACEMENT 25.4 X 90 X 1.2MM (47INCH) ST ULTRAPOWER BUR RND 0.5MM

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)