BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K081647 Instrument, surgical disposable

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    141
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081647

    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    K081647 Instrument, surgical disposable 4" Blade Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Extended Insulation 2.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation; Private Label for Active Medi 33cm Laparoscopic Curved Blade; Blue PTFE; Black Insulation 44cm Lap J-Wire Split; Blue PTFE; Black Insulation 44cm Laparoscopic L-Wire; Blue PTFE; Black Extended Insulation; Private Label for Adler Instruments; 04-500MBXL ES Pencil Rocker Switch; with Holster; 2.5" Blade Tip; Stainless Steel; Blue Insulation 44cm Laparoscopic J-Wire; Blue PTFE; Black Insulation 33cm Laparoscopic Round Spatula; Blue PTFE; Black Insulation; Private Label for Active Medical U0018 2.75" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation; Private label for Mediflex ES Pencil Rocker Switch; with Holster; 2.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended In 33cm Laparoscopic J-Hook Split; Blue PTFE; Black Insulation 37CM Laparoscopic Tip Curved Blade- Blue PTFE - Black Extended Insulation 6.5" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 33cm Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation; Private Label for Surgical Principals MediChoice 6.5" Blade Tip; Blue PTFE; Blue Insulation 33cm Laparoscopic Straight Blade Tip; Blue PTFE; Black Insulation Surgical EZ Kit 5" Tip 5mm Ball Tip; Blue PTFE; Blue Insulation; Black Extended Insulation 2.5" Blade Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Extended Insulation 33cm Laparoscopic Curved Blade; Blue PTFE; Black Insulation; Private Label for Active Medical U0019 6.5" Blade Tip; Stainless Steel; Blue Insulation 2.5" Blade Tip; Stainless Steel; Blue Insulation 33cm Laparoscopic J-Hook; Blue PTFE; Black Insulation; Private label for Surgical Principals U0021 33cm Laparoscopic Curved Blade; Blue PTFE; Black Insulation; Private Label for Surgical Principals U0019 MediChoice 6.5" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 44CM Laparoscopic Straight Blade; Blue PTFE; Black Insulation 44cm Lap L Hook; Blue PTFE; Black Insulation Private Label for Active; U0020L MediChoice; ES Pencil Rocker Switch; with Holster; 2.5" Blade Tip; Blue PTFE; Blue Insulation 2.75" Needle Tip; Blue PTFE; Blue Insulation; Private Label for Mediflex - 91913 33cm Laparoscopic Round Spatula; Blue PTFE; Black Insulation; Private Label for Surgical Principals U0018 6.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation; Private Label for Surgical Pr ES Pencil Rocker Switch; with Holster; 2.75" Blade Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Exte 33cm Laparoscopic J-Hook Split; Blue PTFE; Black Insulation; 04-61SB 2.75" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation-Private Label Surgical Princ 2.75" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 44CM Laparoscopic Round Spatula Split; Blue PTFE; Black Insulation 4CM Tungsten Needle Extended Insulation; No Coating; 2.75"; Blue Insulation; Black Extended Insulation 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; Private Label for Adler Instrument 04-500SMB 44cm Laparoscopic J-Hook; Blue PTFE; Black Insulation 6.5" Needle Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Extended Insulation 4" Blade Tip; Blue PTFE; Blue Insulation ES Pencil Button Switch; with Holster; 2.75" Blade Tip; Blue PTFE; Blue Insulation 2.75" Blade Tip; Blue PTFE; Blue Insulation; Private Label for Active Medical U0012A LLETZ Loop - Round 15mm(W) x 15mm(L) 33cm Laparoscopic L-Hook; Blue PTFE; Black Insulation LLETZ Loop - Round 10mm (W) x 8mm (L) 6.5" Blade Tip; Blue PTFE; Blue Insulation; Private Label for Surgical Principals U0014 3CM Tungsten Needle Extended Insulation; No Coating; 2.25"; Blue Insulation; Black Extended Insulation; Private Label fo 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; Private Label for Active Medical U0100S 44cm Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation; Private Label for Active Medical U0100 ES Pencil Button Switch; with Holster; 2.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended In 3CM Tungsten Needle Extended Insulation; No Coating; 2.25"; Blue Insulation; Black Extended Insulation 33cm Laparoscopic L-Hook Split; Blue PTFE; Black Insulation 2.75" Blade Tip; Blue PTFE; Blue Insulation; Private Label for Surgical Principals U0012A 44cm Laparoscopic L-Hook Split; Blue PTFE; Black Insulation MediChoice 2.5" Blade Tip; Blue PTFE; Blue Insulation 33cm Laparoscopic Narrow Curved Blade; Blue PTFE; Black Insulation U0027 MediChoice; ES Pencil Button Switch; with Holster; 2.5" Blade Tip; Blue PTFE; Blue Insulation Bayonet Blade Extended Insulation; Blue PTFE; Blue Insulation ES Pencil Button Switch; with Holster; 2.5" Blade Tip; Stainless Steel; Blue Insulation ES Pencil Button Switch; with Holster; 2.75" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended I 44cm Laparoscopic L-Hook Split; Blue PTFE; Black Insulation; Private Label for Adler Instrument 04-60SXB MediChoice 6.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 4CM Tungsten Needle Extended Insulation; No Coating; 1.6"; Blue Insulation; Black Extended Insulation; Private Label for 33cm Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation MediChoice 2.75" Blade Tip; Blue PTFE; Blue Insulation MediChoice; ES Pencil Rocker Switch; with Holster; 2.5" Blade Tip; Stainless Steel; Blue Insulation ES Pencil Rocker Switch; with Holster; 2.75" Blade Tip; Blue PTFE; Blue Insulation LLETZ Loop - Round 15mm(W) x 12mm(L) 44cm Laparoscopic L-Hook; Blue PTFE; Black Insulation 2.75" Needle Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Extended Insulation 2.75" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation; Private Label for Active Me 37CM Laparoscopic Curved Blade - Blue PTFE; Black Extended Insulation - Private Label for Adler 04-62B 44CM Laparoscopic L-Wire Split; Blue PTFE; Black Extended Insulation 33cm Laparoscopic J-Wire Split; Blue PTFE; Black Extended Insulation 4" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 5" Tip 5mm Ball; Stainless Steel; Blue Insulation; Black Extended Insulation 33cm Laparoscopic Round Spatula; Blue PTFE; Black Insulation 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; Private Label for Surgical Principals U0100S ES Pencil Button Switch; with Holster; 2.75" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended MediChoice; ES Pencil Button Switch; with Holster; 2.5" Blade Tip; Stainless Steel; Blue Insulation 2.75" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 6.5" Blade Tip; Blue PTFE; Blue Insulation ES Pencil Rocker Switch; with Holster; 2.5" Blade Tip; Blue PTFE; Blue Insulation-Private Label for Active Medical U0030 MediChoice 2.75" Needle Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 44CM Laparoscopic L-Wire Split; Blue PTFE; Black Extended Insulation; Private Label for Adler Instrument 04-500SMBX ES Pencil Button Switch; with Holster; 2.5" Blade Tip; Blue PTFE; Blue Insulation; ACTIVE Part# U0035H ES Pencil Button Switch; with Holster; 2.5" Blade Tip; Blue PTFE; Blue Insulation 33CM Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation; Private Label for Adler Instrument 04- 33cm Laparoscopic Round Spatula Split; Blue PTFE; Black Insulation 33cm Laparoscopic L-Hook; Blue PTFE; Black Insulation; Private Label for Adler Instrument 04-60B 2.5CM Tungsten Needle Extended Insulation; No Coating; 1.6"; Blue Insulation; Black Extended Insulation 33cm Laparoscopic L-Hook; Blue PTFE; Black Insulation; Private Label for Surgical Principals U0020 44CM Laparoscopic Curved Blade; Blue PTFE; Black Insulation LLETZ Loop - Round 10mm (W) x 10mm (L) 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Extended Insulation 33cm Laparoscopic J-Hook; Blue PTFE; Black Insulation; Private Label for Active Medical U0021 4" Blade Tip; Blue PTFE; Blue Insulation; Private Label for Surgical Principals U0014A 2.75" Needle Tip; Stainless Steel; Blue Insulation 33cm Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation; Private Label for Adler Instrument 04- LLETZ Loop - Round 20mm(W) x 12mm(L) 33cm Laparoscopic L-Hook Split; Blue PTFE; Black Insulation; Private Label for Surgical Principals U0020S 33cm Laparoscopic L-Hook Split; Blue PTFE; Black Insulation; Private Label for Adler Instrument 04-60SB 33cm Laparoscopic J-Hook; Blue PTFE; Black Insulation; Private Label for Adler Instrument 04-61B ES Pencil Button Switch; with Holster; 2.75" Blade Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Exte 44CM Laparoscopic Round Spatula; Blue PTFE; Black Insulation 2.75" Needle Tip; Blue PTFE; Blue Insulation 4" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation; Private Label for Surgical Prin MediChoice 2.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation LLETZ Loop - Square 10mm(W) x 10mm(L) 2.75" Blade Tip; Blue PTFE; Blue Insulation MediChoice 2.75" Needle Tip; Blue PTFE; Blue Insulation 44cm Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation; Private Label for Mediflex 91810L 2.75" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation; Private Label for Surgical P 33CM Lap Curved Blade Split 33cm Laparoscopic L-Hook; Blue PTFE; Black Insulation; Private Label for Active Medical U0020 2.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 33cm Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation; Private Label for Mediflex 91810 44cm Laparoscopic L-Hook; Blue PTFE; Black Insulation; Private Label for Surgical Principals U0020L 6.5" Needle Tip; Blue PTFE; Blue Insulation ES Pencil Rocker Switch; with Holster; 2.5" Blade Tip; Blue PTFE; Blue Insulation MediChoice 6.5" Blade Tip; Stainless Steel; Blue Insulation 44cm Laparoscopic L-Wire; Blue PTFE; Black Extended Insulation 33cm Laparoscopic J-Hook; Blue PTFE; Black Insulation 6.5" Blade Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Extended Insulation ES Pencil Button Switch; with Holster; 2.75" Blade Tip; Stainless Steel; Blue Insulation 4CM Tungsten Needle Extended Insulation; No Coating; 2.75"; Blue Insulation; Black Extended Insulation; Private Label fo 33cm Laparoscopic Curved Blade; Blue PTFE; Black Insulation; Private Label for Adler Instrument 04-59B ES Pencil Rocker Switch; with Holster; 2.75" Blade Tip; Stainless Steel; Blue Insulation 6.5" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation 2.5" Blade Tip; Blue PTFE; Blue Insulation 33cm Laparoscopic Straight Blade Tip; Blue PTFE; Black Insulation; Private Label for Surgical Principals U0017 ES Pencil Button Switch; with Holster; 2.75" Needle Tip; Blue PTFE; Blue Insulation 2.75" Blade Tip Extended Insulation; Stainless Steel; Blue Insulation; Black Extended Insulation LLETZ Loop - Round 20mm(W) x 15mm(L) 33cm Laparoscopic J-Wire; Blue PTFE; Black Insulation; Black Extended Insulation 4" Blade Tip; Stainless Steel; Blue Insulation 33cm Laparoscopic L-Wire; Blue PTFE; Black Insulation; Black Extended Insulation; Private Label for Active Medical U0100 44CM Laparoscopic Curved Blade; Blue PTFE; Black Insulation; Private Label for Active Medical U0019L 4" Blade Tip Extended Insulation; Blue PTFE; Blue Insulation; Black Extended Insulation - Private Label for Adler AD2001

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)