FDA.reportPublic FDA data

Skin marking guide, single-use

Definition
A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a single-use device.
GUDID devices
35
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00754027700275RMAC SurgicalRMAC Surgical, IncRM-1450XL2025-06-03
00860010334584InkWell Health Inkwell Health LtdLGLKNEE-MTT-3KT2023-12-20
00860010334591InkWell Health Inkwell Health LtdLGRKNEE-MTT-3KT2023-12-20
00887482012819Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.43-10302024-09-04
00887482012826Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.43-10322024-09-04
10860010334574InkWell Health Inkwell Health LtdLGRKNEE-MTT-3KT2023-12-14
10884389361948MEDLINEMEDLINE INDUSTRIES, INC.DYNJSMD01GS2022-01-01
B971RTC1000SuremarkJessop Precision Products Inc.RadTat2023-01-16
B971RTC120SuremarkJessop Precision Products Inc.RadTat2024-02-01
B971RTD12L0SuremarkJessop Precision Products Inc.RadTat2024-02-01
B971RTD12S0SuremarkJessop Precision Products Inc.RadTat2024-02-01
B971RTL100SuremarkJessop Precision Products Inc.RadTat2023-01-16
M996NL1000NL 100 Breast MarkerINSTRUMENTATION INDUSTRIES, INCORPORATEDNL 1002019-10-01
07540277010041RMAC SurgicalRMAC Surgical, IncSPL-184012026-01-06
00194613121754MSI Precision Specialty InstrumentsMed Saver, Inc.5810572025-08-01
00860010658932FadeMarkEPHEMERAL SOLUTIONS, INC.Version 12025-06-30
10754027700272RMAC SurgicalRMAC Surgical, IncRM-1450XL2025-06-03
10887482012816Symmetry SurgicalSYMMETRY SURGICAL INC.43-10302024-09-04
10887482012823Symmetry SurgicalSYMMETRY SURGICAL INC.43-10322024-09-04
B971RTC121SuremarkJessop Precision Products Inc.RadTat2024-02-01
B971RTD12L1SuremarkJessop Precision Products Inc.RadTat2024-02-01
B971RTD12S1SuremarkJessop Precision Products Inc.RadTat2024-02-01
00860010334560InkWell Health Inkwell Health LtdLGLKNEE-MTT-3KT2023-12-20
00860010334577InkWell Health Inkwell Health LtdLGRKNEE-MTT-3KT2023-12-14
10860010334567InkWell Health Inkwell Health LtdLGLKNEE-MTT-3KT2023-12-14
00850044606009Triangle Template KitMediview Xr, Inc.XR90-CT-KIT2023-10-24
00860010334508InkWell Health Inkwell Health LtdLGLKNEE-MTT2023-08-31
00860010334515InkWell Health Inkwell Health LtdLGLKNEE-MTT-1KT2023-08-31
00860010334522InkWell Health Inkwell Health LtdLGRKNEE-MTT2023-08-31
00860010334539InkWell Health Inkwell Health LtdLGRKNEE-MTT-1KT2023-08-31
40884389361949MEDLINEMEDLINE INDUSTRIES, INC.DYNJSMD01GS2022-01-01
00860003024102AiM Accuracy In Marking SystemAIM MEDICAL TECHNOLOGIES, LLC69-100502020-01-06
10810003223439Pro-PaksMICROSPECIALITIES, INC.MK-90012019-11-13
10810003223446Pro-PaksMICROSPECIALITIES, INC.MK-90022019-11-13
10810003223453Pro-PaksMICROSPECIALITIES, INC.MK-90032019-11-13