BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Skin Marker Accu-Tatt

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    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
    Marker, Skin FZZ

    Proprietary Names

    Skin Marker Accu-Tatt IsoMark 17708/50 SKM503/20 17704/50 17712/50 17702/50 17709/20 17701/50 17703/50 17726/50 ACL Disposable Kit 17706/20 17706/50 Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent Ink; w/ Ruler and Labels Permanent Marker; Round Pen Fine Tip; w/ Labels Permanent Marker; Round Pen Regular Tip; w/ Labels Dual Tip Skin Marker; Regular and Fine Tip Gentian Violet Accu-Tatt Dual Tip Marker, Regular Tip Gentian Violet and Regular Tip Permanent Ink w/ Ruler and Labels Private Labeled for ROI(RO Dual Tip Skin Marker; Regular and Fine Tip Gentian Violet; w/ Ruler and Labels Correct Site Marker; Sharpie Style; w/ Ruler and Labels Skin Marker; Round Pen Regular Tip; w/ Ruler Skin Marker; Round Pen Extra Fine Tip (Green); w/ Ruler Roll Stop Skin Marker; Ruled Cap Regular Tip; w/ Ruler Skin Marker; Round Pen Extra Fine Tip (Green) Skin Marker; Round Pen Fine Tip (Blue); w/ Ruler and Labels Dual Tip Skin Marker; Regular and Fine Tip Skin Marker Gentian Violet; w/ Ruler and Labels; Private Labeled for ROI(ROI Permanent Marker; Round Pen Fine Tip; w/ Ruler and Labels Roll Stop Skin Marker; Ruled Cap Fine Tip; w/ Ruler and Labels Correct Site Marker (small) Roll Stop Skin Marker; Ruled Cap Fine Tip (Blue) Correct Site Marker (small); w/Ruler and Labels Medication Label Marker; Round Pen Regular Tip Skin Marker; Round Pen Fine Tip (Blue); w/ Ruler Dual Tip Skin Marker; Regular and Fine Tip Gentian Violet; w/ Ruler; Private Label for SMI Correct Site Marker; Sharpie Style; w/ Ruler Correct Site Marker; Round Regular Tip Skin Marker; Round Pen Regular Tip Permanent Marker; Round Pen Regular Tip (Purple) Roll Stop Skin Marker; Ruled Cap Regular Tip; w/ Ruler and Labels Correct Site Marker; Sharpie Style Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent Ink; w/ Ruler Permanent Marker; Round Pen Fine Tip (Blue) Skin Marker; Round Pen Regular Tip; w/ Ruler and Labels Roll Stop Skin Marker; Ruled Cap Regular Tip Dual Tip Skin Marker; Regular and Fine Tip Skin Marker Gentian Violet; Private Label for Medichoice Roll Stop Skin Marker; Ruled Cap Fine Tip; w/ Ruler Correct Site Marker; Round Regular Tip; w/ Ruler and Labels Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent Ink Dual Tip Skin Marker; Regular and Fine Tip Gentian Violet; w/ Ruler

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)