BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reprocessed surgical instruments

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    344
    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
    Instrument, Surgical, Disposable KDC

    Proprietary Names

    Reprocessed surgical instruments Y-TEC Peritoneal Dialysis Catheter Implantation Pacs Cuff Implantor KI9384/12 12-203/20 14901/25 17705/10 KI086SS/20 19-360/20 24-689SPC/20 25-710/20 SOAR Beveled Portal Tube Catalog# 306-1804 SOAR Portal Tube Catalog# 304-1507 Argyle Vascular Tourniquet Kit 17050/50 19245/50 17441/24 25-705/20 KI922/20 KI031/20 17771/100 15202/100 KI076/50 17024/20 25-107/20 17455/50 KI028/20 KN2405/10 27-734R/60 11-177 RED/20 KI0104/50 KI160/20 11-159A/20 25-749/20 17630/20 17713/20 OEIT01/20 32-914/20 SOAR Beveled Portal Tube Catalog# 306-1509 SOAR Beveled Portal Tube Catalog# 306-2211 SOAR Beveled Portal Tube Catalog# 306-2212 SOAR Beveled Portal Tube Catalog# 306-1510 SOAR Portal Tube Catalog# 304-1207 HK008/50 25-696/20 17405/48 17033/50 20-372S/20 27-776/20 17130/50 17405/10 19-363/50 16-296/20 SP62/50 14906/20 25-751/20 Spineology Expandable Rake (Toothed) Catalog# 315-0027 SOAR Portal Tube Catalog# 304-1510 KI140/05 11-177 BK/20 28855/20 12-202K/20 17640/15 15202/25 12-206/20 KI0127/50 MED27-752/20 Spineology Expandable Rake (Non-Toothed) Catalog# 315-0028 TOQ634 SOAR Beveled Portal Tube Catalog# 306-1504 KI076NT/20 25-746/20 SOAR Beveled Portal Tube Catalog# 306-1507 19227/20 15001/100 MED25-751/20 MED27-734/20 15232/50 15302/50 19230/20 15101/100 PL-8037/100 24-666/20 KI082/50 MED27-732/20 KN2605/10 KI056/50 2511/25 18-331S/50 KI095/50 24-712/20 SOAR Portal Tube Catalog# 304-1210 SOAR Portal Tube Catalog# 304-1811 SOAR Portal Tube Catalog# 304-1509 27-784-S/20 463-004-PK/20 27-774S/20 17125/50 17406/48 KI032/20 KI032/50 19-366/20 N0522S/24 SOAR Portal Tube Catalog# 304-2210 SOAR Portal Tube Catalog# 304-1806 SOAR Beveled Portal Tube Catalog# 306-1807 SOAR Portal Tube Catalog# 304-1204 SOAR Portal Tube Catalog# 304-2611 SOAR Beveled Portal Tube Catalog# 306-2204 SOAR Beveled Portal Tube Catalog# 306-1810 KS355/50 15201/100 17625/20 KN1415/10 02-445/20 24-710/20 KI079/20 Key Surgical® Vascular Loops SOAR Portal Tube Catalog# 304-1203 SOAR Portal Tube Catalog# 304-2209 SOAR Beveled Portal Tube Catalog# 306-1508 SOAR Portal Tube Catalog# 304-1209 SOAR Beveled Portal Tube Catalog# 306-2205 MCS100 24-684/20 312-640/20 25-775B/20 17119/50 19221/20 17618/25 17724/50 KN2738/50 27-802/10 KI096S/20 KI081/50 11-138S/20 17358/25 SOAR Beveled Portal Tube Catalog# 306-2209 SOAR Portal Tube Catalog# 304-2205 SOAR Portal Tube Catalog# 304-2606 18-346/20 11-139S/20 25-711/20 TOQ635 17355/50 19902/20 17626/25 32-916/20 29-860/20 17508/24 15221/100 95-551/50 KI074/20 KN2505/10 13-241/20 KI049/20 27-796/20 17624/25 SOAR Portal Tube Catalog# 304-1211 SOAR Portal Tube Catalog# 304-2605 Spineology E Blade Catalog# 315-0014 SOAR Beveled Portal Tube Catalog# 306-1805 SOAR Portal Tube Catalog# 304-1511 SOAR Portal Tube Catalog# 304-1508 19-349FPS/20 KF305/25 17432/24 NED001/10 BHIC01/10 KI084S/20 32-911/20 27-750/20 KN2805/10 25-711A/20 KI026/20 MAGP01/20 KI9390/20 SOAR Beveled Portal Tube Catalog# 306-2207 KI069/20 27-790/20 17566/25 25-702/20 TOQ630 KI0154/20 15301/100 KI150/10 TOQ633 KI083K/50 11-134/20 11-182/50 16-277/20 KI0134/20 27-734/20 KIW95/20 27-736R/60 19222/20 27-784/20 GS94-952/01 KN2615/10 KN7516/25 KN2815/10 KI086S/20 KI078/20 17125/10 11-176 BK/20 27-752/20 24-689B/20 11-119C/20 KI061/50 14-257/20 16-254-LRS/20 17120/50 24-684-A/20 9595/50 KI086/20 KI077/20 25-699/50 25-746S/20 2510/50 SOAR Portal Tube Catalog# 304-1212 SOAR Portal Tube Catalog# 304-1206 TOQ632 19260/20 KI071/20 32-913/20 15205/100 KI0137/20 17360/25 KI122/20 SOAR Portal Tube Catalog# 304-1807 Spineology SIFS Blade Catalog# 330-0012 SOAR Beveled Portal Tube Catalog# 306-2208 SOAR Portal Tube Catalog# 304-1205 SOAR Portal Tube Catalog# 304-2608 SOAR Beveled Portal Tube Catalog# 306-1505 SOAR Portal Tube Catalog# 304-1512 SOAR Beveled Portal Tube Catalog# 306-1812 SOAR Beveled Portal Tube Catalog# 306-1811 SOAR Portal Tube Catalog# 304-1810 SOAR Beveled Portal Tube Catalog# 306-1806 SOAR Beveled Portal Tube Catalog# 306-1808 KI084/50 25-706/20 KI055/20 15022/50 323-01/20 19250/20 KN2415/10 15000/100 13-243/20 14-252/20 19960/10 KI160/50 MED27-736/20 19-350EFP/50 19240/25 15304/100 KI130/05 SP55/50 KI071/50 SOAR Portal Tube Catalog# 304-1504 15102S/100 HSC001/20 12-203K/20 KI031/50 19940/10 25-699/20 17525/25 560-755/01 SOAR Portal Tube Catalog# 304-1809 SOAR Portal Tube Catalog# 304-2211 SOAR Portal Tube Catalog# 304-2207 SOAR Beveled Portal Tube Catalog# 306-1809 SOAR Portal Tube Catalog# 304-1208 SP40/50 14-250/20 403-026-PK/20 24-708/20 27-734R/90 32-915/20 GS94-955/01 TOQ631 SOAR Beveled Portal Tube Catalog# 306-1511 SOAR Portal Tube Catalog# 304-2208 KI075/50 SOAR Portal Tube Catalog# 304-2609 18345/24 11-185SS/20 24-706/20 17435/20 KI025/20 17645/15 SOAR Portal Tube Catalog# 304-2206 SOAR Portal Tube Catalog# 304-2212 SOAR Portal Tube Catalog# 304-1506 15002/100 KI695/20 KI094/50 24-697/20 14-256S/20 16194/25 KIW91/50 SOAR Portal Tube Catalog# 304-1805 SOAR Portal Tube Catalog# 304-2607 17408/48 11-119S/20 25-717/20 KI118/100 MED27-750/20 19-362/20 KI1107/50 16-285LR/20 24-663/50 KI051/20 27-763A/20 KI072/20 02-447/20 KI035/50 KN2515/10 27-732/20 02-446/20 TD-6008/20 KI025/10 SOAR Portal Tube Catalog# 304-1808 SOAR Portal Tube Catalog# 304-2610 SOAR Portal Tube Catalog# 304-1812 SOAR Portal Tube Catalog# 304-1505 SOAR Beveled Portal Tube Catalog# 306-2210 SOAR Portal Tube Catalog# 304-2612 SOAR Beveled Portal Tube Catalog# 306-2206 15-274/20 19950/10 27-732R/60 15102/100 2110SA/25 27-736/20 EWST01/20 SOAR Portal Tube Catalog# 304-1804 SOAR Beveled Portal Tube Catalog# 306-1506 SOAR Beveled Portal Tube Catalog# 306-1512 SJM Leaflet Tester Argyle Vascular Tourniquet Kit: 8888585000 SCALPEL, HEMOSTAT, NEEDLE HOLDER, SCISSOR, FORCEP Anspach Bone Collector

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)