BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hip Preservation Sys

    Reg #: 1054811 · FEI: 1000114185 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    87
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    1054811
    FEI Number
    1000114185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    502 Prairie Mine Rd
    City
    MULBERRY
    State
    FL
    ZIP
    33860
    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
    Accessories, Arthroscopic NBH

    Proprietary Names

    Hip Preservation Sys EndoRelease Cubital Tunnel Release System SharpShooter Handle FlowPort Cannula Reprocessed Arthroscopic Accessories CMI Measuring Rod (Production) INTEQ Suturing kit Scope Shield Blitz Suture Retriever Disposable Cannula Cannula, Cannuloc, disposable Universal Cannula Hex-Flex with disposable obturalor DryDoc Cannula Hex-Flex Disposable Cannula Dry Doc Cannula W/Disp. Obturator Dry Dooc Cannula, Non Fenestrated Astroscopy Cannula Cannuloc, disposable cannula Flexible Cannula Ceterix Disposable Knot Pusher CapsulePass Suture Passer TwoVu ST-6 Integra Endorelease Cubital Tunnel Release System NovoCut Suture Manager FirstPass ST Suture Passer, Self Capture TwoVu ST-6-130 HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 8 X 85MM, QTY 6 HEX-FLEX CANNULA WITH DISPOSABLE OBTURATOR 6 X 85MM, QTY 6 TwoVu ST-6-134 TwoVu ST-6L BLITZ SUTURE RETRIEVER, STRAIGHT, 6 EA 6MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA 8.4MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA FirstPass ST Suture Passer, Standard TwoVu ST-5 HIP PRESERVATION SYSTEM SWITCHING STICK PACK, QTY 1 Exstravastopper Y-Knot DryVu Adjustable Retractor Cannula 8mm x 65mm 6MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR, 5 X 85MM, QTY 6 5.5MM (I.D.) X 70MM SHOULDER CANNULA SET WITHOUT FENESTRATIONS, 10 EA ClearVu 2.7 Blunt 6.5 X 73MM CLEAR FLEXIBLE CANNULA, 6 EA 6.5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED, QTY 6 Y-KNOT FLEX HIP DISPOSABLE FLEXIBLE OBTURATOR, BLUNT Y-Knot, Flex Disposable Flexible Obturator, Blunt 8.4MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA 8.4MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 7 X 85MM, QTY 6 DRY DOC CANNULA WITH DISPOSABLE OBTURATOR 8 X 75MM, QTY 6 ClearVu 2.7 Sharp 8.4MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 7 X 85MM, QTY 6 CANN DRY DOC 8.4X75MM 6 EA 6MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA 8.4MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA Adjustable Retractor Cannula 6mm x 65mm 6MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA 6MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 7 X 95MM, QTY 6 HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 5 X 85MM, QTY 6 DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 8 X 85MM, QTY 6 Y-Knot, Flex Disposable Flexible, Trocar 8.4MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA 8 X 120MM HIP PRESERVATION SYSTEM ARTHROSCOPY CANNULA, QTY 6 Adjustable Retractor Cannula 8mm x 85mm Adjustable Retractor Cannula 6mm x 85mm with outflow 5.5MM (I.D.) X 70MM UNIVERSAL CANNULA SET WITH FENESTRATIONS, 10 EA CrossFix II Disposable Kit HIP PRESERVATION SYSTEM HIP ACCESS NEEDLE PACK, 17G, QTY 2 DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR, 6 X 85MM, QTY 6 0234-020-165;3910-075-500;3910-075-501;3910-075-650;3910-075-651;3910-075-800;3910-090-650;3910-090-800 Cubital Tunnel Release System EGR System Arthroscopic Accessories Accessories, Arthroscopic Remote Control Drape 3910-075-801 MicroAire Endoscopic Release System - Various Accessories Hi-Flow Cannula 3910-090-500 CMI Measuring Rod (dose audit) Endoscopic Gastroc Release (EGR) System SafeGuard Carpal Tunnel Release System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)