FDA.reportPublic FDA data

Skin marking pen, single-use

Definition
A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.
GUDID devices
625
Last updated
2026-06-13 06:05:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
50885380179684CARDINAL HEALTHCardinal Health 200, LLC2905BN2020-09-02
50885380179691CARDINAL HEALTHCardinal Health 200, LLCCSPP-12020-09-02
50885380179707CARDINAL HEALTHCardinal Health 200, LLCGFP-12020-09-02
50885380179714CARDINAL HEALTHCardinal Health 200, LLCGP-1Z2020-09-02
50885380179721CARDINAL HEALTHCardinal Health 200, LLCPP-1002020-09-02
50885380179738CARDINAL HEALTHCardinal Health 200, LLCSU-1Z2020-09-02
50885380179776CARDINAL HEALTHCardinal Health 200, LLCWP-12020-09-02
00612479259041MckessonMCKESSON MEDICAL-SURGICAL INC.19-07622020-08-10
00612479259065MckessonMCKESSON MEDICAL-SURGICAL INC.19-07412020-08-10
00630094177267Bioseal Inc.BIOSEAL17726/502023-10-03
00630094177274Bioseal Inc.BIOSEAL17727/502023-10-03
00661392004511LSL HEALTHCARELSL Industries, LLCM26-0012025-10-30
00661392004528LSL HEALTHCARELSL Industries, LLCM26-0022025-10-30
00690521014923Batrik SkinsBatrik Medical Manufacturing IncS-30012020-09-25
00749756024211DeRoyalDEROYAL INDUSTRIES, INC.26-0012021-06-29
00749756024266DeRoyalDEROYAL INDUSTRIES, INC.26-0032021-06-29
00749756119917DeRoyalDEROYAL INDUSTRIES, INC.26-0052021-06-29
00749756157476DeRoyalDEROYAL INDUSTRIES, INC.26-0042021-06-29
00749756157483DeRoyalDEROYAL INDUSTRIES, INC.26-0022021-06-29
00749756158879DeRoyalDEROYAL INDUSTRIES, INC.26-003NS2021-06-29
00749756240505DeRoyalDEROYAL INDUSTRIES, INC.26-005NS2021-06-29
00749756240512DeRoyalDEROYAL INDUSTRIES, INC.26-001NS2021-06-29
00749756240536DeRoyalDEROYAL INDUSTRIES, INC.26-002NS2021-06-29
00749756240543DeRoyalDEROYAL INDUSTRIES, INC.26-006NS2021-06-30
00749756240550DeRoyalDEROYAL INDUSTRIES, INC.26-0062021-06-30
00749756615587DeRoyalDEROYAL INDUSTRIES, INC.77-4005642021-07-12
00749756615600DeRoyalDEROYAL INDUSTRIES, INC.77-4005662021-07-12
00749756643207DeRoyalDEROYAL INDUSTRIES, INC.26-017NS2021-06-30
00749756671583DeRoyalDEROYAL INDUSTRIES, INC.26-018NS2021-06-30
00749756811675DeRoyalDEROYAL INDUSTRIES, INC.26-0192021-06-30
00749756811682DeRoyalDEROYAL INDUSTRIES, INC.26-019NS2021-06-30
00749756813716DeRoyalDEROYAL INDUSTRIES, INC.26-0202021-06-30
00749756873345DeRoyalDEROYAL INDUSTRIES, INC.26-018PRNS2021-06-30
00749756873352DeRoyalDEROYAL INDUSTRIES, INC.26-001PR2021-06-29
00749756873369DeRoyalDEROYAL INDUSTRIES, INC.26-003PR2021-06-29
00749756873376DeRoyalDEROYAL INDUSTRIES, INC.26-005PR2021-06-29
00749756873383DeRoyalDEROYAL INDUSTRIES, INC.26-005PRNS2021-06-30
0078755100311610735 Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent InkXODUS MEDICAL, INC.107352022-12-08
0078755100821010400 Correct Site Marker; Sharpie StyleXODUS MEDICAL, INC.104002022-12-08
0078755100822710402 Correct Site Marker (small)XODUS MEDICAL, INC.104022022-12-08
0078755100823410402MERCY Correct Site Marker (small); PLXODUS MEDICAL, INC.10402MERCY2022-12-08
0078755100824110403 Correct Site Marker (small); w/RulerXODUS MEDICAL, INC.104032022-12-08
0078755100825810404 Correct Site Marker (small); w/Ruler and LabelsXODUS MEDICAL, INC.104042022-12-08
0078755100826510405 Permanent Marker; Round Pen Regular Tip (Purple)XODUS MEDICAL, INC.104052022-12-08
0078755100827210406 Permanent Marker; Round Pen Regular Tip; w/ LabelsXODUS MEDICAL, INC.104062022-12-08
0078755100828910407 Permanent Marker; Round Pen Regular Tip; w/ Ruler and LabelsXODUS MEDICAL, INC.104072022-12-08
0078755100829610411 Correct Site Marker; Sharpie Style; w/ Ruler and LabelsXODUS MEDICAL, INC.104112022-12-08
0078755100830210412 Correct Site Marker; Sharpie Style; w/ RulerXODUS MEDICAL, INC.104122022-12-08
0078755100831910415 Permanent Marker; Round Pen Fine Tip (Blue)XODUS MEDICAL, INC.104152022-12-08
0078755100832610416 Permanent Marker; Round Pen Fine Tip; w/ LabelsXODUS MEDICAL, INC.104162022-12-08
0078755100833310417 Permanent Marker; Round Pen Fine Tip; w/ Ruler and LabelsXODUS MEDICAL, INC.104172022-12-08
0078755100834010500 Roll Stop Skin Marker; Ruled Cap Regular Tip; w/ RulerXODUS MEDICAL, INC.105002022-12-08
0078755100835710511 Roll Stop Skin Marker; Ruled Cap Fine Tip; w/ RulerXODUS MEDICAL, INC.105112022-12-08
0078755100836410600 Roll Stop Skin Marker; Ruled Cap Regular Tip; w/ Ruler and LabelsXODUS MEDICAL, INC.106002022-12-08
0078755100837110611 Roll Stop Skin Marker; Ruled Cap Fine Tip; w/ Ruler and LabelsXODUS MEDICAL, INC.106112022-12-08
0078755100838810700 Roll Stop Skin Marker; Ruled Cap Regular TipXODUS MEDICAL, INC.107002022-12-08
0078755100840110711 Roll Stop Skin Marker; Ruled Cap Fine Tip (Blue)XODUS MEDICAL, INC.107112022-12-08
0078755100841810715 Skin Marker; Round Pen Regular TipXODUS MEDICAL, INC.107152022-12-08
0078755100842510716 Skin Marker; Round Pen Fine Tip (Blue)XODUS MEDICAL, INC.107162022-12-08
0078755100843210717 Skin Marker; Round Pen Regular Tip; w/ Ruler and LabelsXODUS MEDICAL, INC.107172022-12-08
0078755100844910718 Skin Marker; Round Pen Regular Tip; w/ RulerXODUS MEDICAL, INC.107182022-12-08
0078755100845610719 Skin Marker; Round Pen Fine Tip (Blue); w/ Ruler and LabelsXODUS MEDICAL, INC.107192022-12-08
0078755100846310720 Skin Marker; Round Pen Fine Tip (Blue); w/ RulerXODUS MEDICAL, INC.107202022-12-08
0078755100847010725 Correct Site Marker; Round Regular TipXODUS MEDICAL, INC.107252022-12-08
0078755100848710726 Correct Site Marker; Round Regular Tip; w/ RulerXODUS MEDICAL, INC.107262022-12-08
0078755100849410727 Correct Site Marker; Round Regular Tip; w/ Ruler and LabelsXODUS MEDICAL, INC.107272022-12-08
0078755100850010730 Medication Label Marker; Round Pen Regular TipXODUS MEDICAL, INC.107302022-12-08
0078755100851710731 Dual Tip Skin Marker; Regular and Fine Tip Gentian VioletXODUS MEDICAL, INC.107312022-12-08
0078755100852410732 Dual Tip Skin Marker; Regular/Fine Tip Gentian Violet; w/Ruler and LabelsXODUS MEDICAL, INC.107322022-12-13
0078755100853110732ROI Dual Tip Skin Mrkr; Reg/Fine Skin Mrkr Gentian Vlt; w/Ruler/Label; PLXODUS MEDICAL, INC.10732ROI2022-12-13
0078755100854810733 Dual Tip Skin Marker; Regular and Fine Tip Gentian Violet; w/ RulerXODUS MEDICAL, INC.107332022-12-08
0078755100855510736 Dual Tip Marker; Regular Tip Gentian Violet and Perm Ink; w/Ruler/LabelsXODUS MEDICAL, INC.107362022-12-13
0078755100856210736ROI Dual Tip Mrkr, Reg Gentian Violet/Permanent Ink w/Ruler and Labels PLXODUS MEDICAL, INC.10736ROI2022-12-13
0078755100857910737 Dual Tip Marker; Regular Tip Gentian Violet and Permanent Ink; w/RulerXODUS MEDICAL, INC.107372022-12-13
0078755100858610746 Skin Marker; Round Pen Extra Fine Tip (Green)XODUS MEDICAL, INC.107462022-12-08
0078755100859310747 Skin Marker; Round Pen Extra Fine Tip (Green); w/ RulerXODUS MEDICAL, INC.107472022-12-08
00787551008616NS10400 Correct Site Marker; Sharpie StyleXODUS MEDICAL, INC.NS104002022-12-08
00787551008623NS10402 Correct Site Marker(small); Gentian Violet Ink; In Dispenser Box(50/box)XODUS MEDICAL, INC.NS104022022-12-13
00787551008661NS10402WEBB Correct Site Marker (small)XODUS MEDICAL, INC.NS10402WEBB2022-12-08
00787551008678NS10405 Permanent Marker; Round Pen Regular Tip (purple)XODUS MEDICAL, INC.NS104052022-12-08