FDA.reportPublic FDA data

Skin marking transfer paper

Definition
A non-sterile, noninvasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure, such as accurate subcutaneous injection spacing. It is a non-latex transfer paper designed to be applied to the skin and then peeled away to leave the ink dots, which are subsequently removed from the skin (e.g., with alcohol) after the procedure. This is a single-use device.
GUDID devices
23
Last updated
2026-06-11 06:05:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841439115237Opti-TattQfixUTRT-41002026-05-29
00841439115244Opti-TattQfixUTRT-42002026-05-29
00841439115251Opti-TattQfixUTRT-43002026-05-29
00714646000996Opti-Tatt™ DotsBionix, LLCUTRT-41002023-06-12
00714646001009Opti-Tatt™ CrosshairsBionix, LLCUTRT-42002023-06-12
00714646001016Opti-Tatt™ Field BordersBionix, LLCUTRT-43002023-06-12
00714646001023Sample: Opti-Tatt DotsBionix, LLCSP-241002023-06-12
10888628044975Skin Marking GridAllergan, Inc.964332022-12-08
10714646001129Sample: Opti-TattBionix, LLC241002025-06-20
10714646000993Opti-Tatt™ DotsBionix, LLCUTRT-41002023-06-12
10714646001006Opti-Tatt™ CrosshairsBionix, LLCUTRT-42002023-06-12
10714646001013Opti-Tatt™ Field BordersBionix, LLCUTRT-43002023-06-12
10714646001020Sample: Opti-Tatt DotsBionix, LLCSP-241002023-06-12
00850608002209ThermageSOLTA MEDICALTK-0.252016-09-23
00850608002216ThermageSOLTA MEDICALTK-16.002016-09-23
00850608002223ThermageSOLTA MEDICALTK-3.002016-09-23
00850608002230ThermageSOLTA MEDICALTK-3.00-L2016-09-23
00816995021292THERMAGE FLXSOLTA MEDICALSM-0.252017-11-08
00816995021308THERMAGE FLXSOLTA MEDICALSM-3.002017-11-08
00816995021315THERMAGE FLXSOLTA MEDICALSM-3.00-L2017-12-14
00816995021322THERMAGE FLXSOLTA MEDICALSM-4.002017-12-14
00816995021339THERMAGE FLXSOLTA MEDICALSM-16.002017-12-14
00816995026914THERMAGE FLXSOLTA MEDICALSM-4.00-L2017-12-14