BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Badger

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    67
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    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
    Bit, Surgical GFG

    Proprietary Names

    Badger MICRO PILOT DRILL Y-Knot E9000 Bur C-Reamer XO Button SENTINEL Y-KNOT FLEX 1.8MM, DISPOSABLE DRILL BIT 6.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 C-REAMER, CANNULATED 6MM QTY 4 6 X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 C-REAMER, CANNULATED 7MM, QTY 4 8.5MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 12.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 MICRO PILOT DRILL, SHORT 2 X 15MM MICRO PILOT DRILL, SHORT 1.5 X 15MM Y-KNOT ALL-SUTURE ANCHOR DRILL BIT 1.3MM 7.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 10 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 GRAFTMAX INDICATOR PIN 7MM X 229MM (9 IN) BADGER CANNULATED BADGER DRILL BIT, QTY 4 9MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 5MM BADGER DRILL BIT, QTY 4 7.5MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 C-REAMER, CANNULATED 8MM, QTY 4 E9000 BUR WIRE PASS 2 X 38MM 6 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 Y-KNOT FLEX 1.3MM DISPOSABLE DRILL BIT FOR HARD BONE 12MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 10.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 ULTRAPOWER DEPTH LIMITING DRILL (COPPER) 1.1 X 9MM Y-KNOT FLEX, 1.3MM, DISPOSABLE DRILL BIT 10.5MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 GRAFTMAX FLEX XACTPIN GUIDE PIN 12 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 Y-Knot® Flex Hip Disposable Drill Pack for 1.3mm Anchor Y-Knot RC Disposable Drill Bit, 2.8mm MICRO PILOT DRILL, SHORT 1.5 X 10MM 8MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 C-REAMER, CANNULATED 11MM, QTY 4 Y-Knot® Flex Hip Disposable Drill Pack for 1.8mm Anchor 6.5 X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 11.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 13MM DIA. X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 10MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 13 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 5.5 X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 NEURAIRTOME WIRE PASS DRILL, QTY 5 CrossFT Knotless 4 Drill Bit, Disposable 1.1 X 3.5MM ULTRAPOWER DEPTH LIMITING DRILL (COPPER) 9 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 C-REAMER, CANNULATED 12MM, QTY 4 9.5MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 9.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 8 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 XACTPIN GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (93 X 17IN) C-REAMER, CANNULATED 9MM, QTY 4 E9000 BUR WIRE PASS 1 X 38MM C-REAMER, CANNULATED 10MM, QTY 4 8.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 11MM X 229MM (9 IN) BADGER CANNULATED DRILL BIT, QTY 4 1.5MM X 7MM ULTRAPOWER DEPTH LIMITING DRILL (COPPER) 7 X 299MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 11 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 Y-KNOT ALL-SUTURE ANCHOR DRILL BIT WITH PEEK BEARING 5.5 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4 5 X 229MM (9 IN) XO BUTTON CANNULATED DRILL BIT, QTY 4

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)