BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FlexAccess 04/20 25mm

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    49
    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

    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
    File, Pulp Canal, Endodontic EKS

    Proprietary Names

    FlexAccess 04/20 25mm WaveOne Gold Reciprocating File Medium 25mm WaveOne Gold Reciprocating File Large 25mm DEMO TRUShape 3D Conforming File Size 25 31mm FlexAccess 04/15 25mm WaveOne Gold Reciprocating File Medium 21mm TRUShape 3D Conforming File Size 25 21mm WaveOne Gold Reciprocating File Large 31mm TRUShape 3D Conforming File Size 40 21mm TRUShape 3D Conforming File Size 20 31mm FlexAccess 04/30 25mm WaveOne Gold Reciprocating File Small 25mm WaveOne Gold Reciprocating File Medium 25mm DEMO TRUShape 3D Conforming File Size 30 25mm TRUShape 3D Conforming File Size 20 21mm FlexAccess 04/30 21mm FlexAccess 04/20 21mm WaveOne Gold Reciprocating File Small 31mm FlexAccess 04/15 30mm TRUShape 3D Conforming File Size 40 25mm TRUShape 3D Conforming File Size 30 21mm FlexAccess 04/25 30mm WaveOne Gold Reciprocating File Primary 21mm FlexAccess 04/30 30mm WaveOne Gold Reciprocating File Small 25mm DEMO FlexAccess 04/25 25mm WaveOne Gold Reciprocating File Primary 31mm FlexAccess 04/15 21mm WaveOne Gold Reciprocating File Large 21mm WaveOne Gold Reciprocating File Large 25mm TruShape Orifice Modifier 16mm WaveOne Gold Reciprocating File Primary 25mm TRUShape 3D Conforming File Size 20 25mm WaveOne Gold Reciprocating File Small 21mm TRUShape 3D Conforming File Size 40 31mm FlexAccess 04/25 21mm WaveOne Gold Reciprocating File Primary 25mm DEMO TRUShape 3D Conforming File Size 25 25mm WaveOne Gold Reciprocating File Primary 21mm DEMO FlexAccess 04/20 30mm WaveOne Gold Glider TRUShape 3D Conforming File Size 30 31mm WaveOne Gold Reciprocating File Medium 31mm WaveOne Gold Reciprocating File Small 21mm DEMO ProTaper Next Trunatomy TruShape Files Waveone gold files ProGlider

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)