BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reprocessed surgical instruments

    Reg #: 2029015 · FEI: 1000160458 · 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
    2029015
    FEI Number
    1000160458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    687 S Wanamaker Ave
    City
    Ontario
    State
    CA
    ZIP
    91761
    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)