BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Trocar Cleaner - XL 12 mm

    Reg #: 1423662 · FEI: 3000215273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1423662
    FEI Number
    3000215273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1003 Lakeside Drive
    City
    Gurnee
    State
    IL
    ZIP
    60031
    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, Manual, Surgical, General Use MDM

    Proprietary Names

    Trocar Cleaner - XL 12 mm Guide Pin 2.4 x 508 R/R Package ASM, No. 300-1011 Guide Pin 2.4 x 508 T/R Package ASM, No. 300-1010 DS Portal Tube Package ASM, No. 550-0013 Portal Tube Package ASM, No. 315-0016 Guide Pin 1.1 x 635 Package ASM, No. 430-0041 INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Locking Delivery Cannula 3-11.5-ED StabiliT Delivery Instruments, Long StabiliT Introducer 3.6-D FlexDex Needle Driver StabiliT Introducer 3.6-11.5-EB 45 DEGREE BLITZ SUTURE RETRIEVER, RIGHT, 6 EA Locking Delivery Cannula 3 DermaBlade® ARTHROSCOPY KNIFE, RETROGADE, SMALL JOINT, 2.4mm, QTY 4 StabiliT Introducer 3.6-11.5-ED HIGH STRENGTH BREAKAWAY GUIDE PIN, 9 IN, STERILE, 2.4 X 229MM (93 X 9IN) 45 DEGREE BLITZ SUTURE RETRIEVER, LEFT, 6 EA 2.4MM ARTHROSCOPY KNIFE, SMILLIE, SMALL JOINT, QTY 4 StabiliT Introducer 3.6-B Spineology Guide Pin Catalog# 530-0089 SUTURE SAVER KIT, QTY 5 Spineology Guide Pin Catalog# 300-1011 42-3100 2.4MM ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, 4 EA SE GRAFT TENSIONER BREAKAWAY PINS WITH GRAFT TENSION CALCULATOR, QTY 5 StabiliT Delivery Instruments, Short HIGH STRENGTH BREAKAWAY GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (93 X 12IN) Spineology Guide Pin Catalog# 300-1010 BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL, 14 IN, STERILE, 0.8 X 356MM (32 X 14IN) Spineology Guide Pin Catalog# 430-0041 Spineology Guide Pin Catalog# 530-0088 Spineology Diverted Fill Tube Catalog# 300-0009 Spineology Guide Pin Catalog# 530-0087 MedOne Yankauer Suction Device Guide Pin 2.4 x 508 T/R Package ASM, #300-1010 Guide Pin 2.4 x 508 R/R Package ASM, #300-1011 Guide Pin 1.1 x 635 Package ASM, #430-0041 Portal Tube Package ASM, # 315-0016 NM Dilator One, #315-0012 DS Portal Tube Package ASM, # 550-0013 DermaBlade

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)