FDA.reportPublic FDA data

Scar-management dressing, single-use

Definition
A covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). After application, this device cannot be reused.
GUDID devices
65
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00070030511739SCARAWAY SILICONE GEL 20GL PERRIGO COMPANY11A3QSAC12021-03-17
00358962203107ScarAway Silicone Scar GelAlliance Pharma Inc.Lot Code2024-04-09
00825439012062MediClear™ Scar 10x10Covalon Technologies Ltd90010102023-07-14
00825439012260MediClear™ Scar 4x4Covalon Technologies Ltd90004042023-07-14
00825439012291MediClear™ Scar 6x7Covalon Technologies Ltd90006072023-07-14
00825439012321MediClear™ Scar 6x30Covalon Technologies Ltd90006302023-07-14
04719859641901H&HTRONJEN MEDICAL TECHNOLOGY INC.HW21062020-06-12
04719859641918H&HTRONJEN MEDICAL TECHNOLOGY INC.HW12062020-06-12
04719859641925H&HTRONJEN MEDICAL TECHNOLOGY INC.HW05052020-06-12
04719859642038H&HTRONJEN MEDICAL TECHNOLOGY INC.SH12062020-06-12
04719859642045H&HTRONJEN MEDICAL TECHNOLOGY INC.SH05052020-06-12
04719859642052H&HTRONJEN MEDICAL TECHNOLOGY INC.SH21062020-06-12
04719884330108H&HTRONJEN MEDICAL TECHNOLOGY INC.HW21062023-07-20
04719884330115H&HTRONJEN MEDICAL TECHNOLOGY INC.HW12062023-07-20
04719884330122H&HTRONJEN MEDICAL TECHNOLOGY INC.HW05052023-07-20
04719884330238H&HTRONJEN MEDICAL TECHNOLOGY INC.SH12062023-07-20
04719884330245H&HTRONJEN MEDICAL TECHNOLOGY INC.SH05052023-07-20
04719884330252H&HTRONJEN MEDICAL TECHNOLOGY INC.SH21062023-07-20
05000223482589CICA CARESMITH & NEPHEW MEDICAL LIMITED668014912026-04-30
05000223502157CICA CARESMITH & NEPHEW MEDICAL LIMITED668031842026-04-30
06974795050141NAHenan Maidingkang Medical Technology Co., Ltd.Non-Sterile2022-06-03
07323190127108Mepiform®Mölnlycke Health Care AB2932882020-07-28
07332430998880Mepiform®Mölnlycke Health Care AB2936002022-10-21
07332430998897Mepiform®Mölnlycke Health Care AB2937002022-10-21
07332430998903Mepiform®Mölnlycke Health Care AB2938002022-10-21
04719884330269H&HTRONJEN MEDICAL TECHNOLOGY INC.SC21062025-12-12
04719884330368H&HTRONJEN MEDICAL TECHNOLOGY INC.SC21062025-12-12
04719884333765H&HTRONJEN MEDICAL TECHNOLOGY INC.SG00072025-12-11
00816465020046NewGel+UV Silicone Gel for Scars + SPF30Newmedical Technology, Inc.80152025-08-07
00816465020213Silagen 100% Pure Silicone GelNewmedical Technology, Inc.61152025-08-07
00816465020220Silagen 100% Pure Silicone GelNewmedical Technology, Inc.61302025-08-07
00816465020237Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.62302025-08-07
00816465020244Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.62152025-08-07
00816465020299NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.NGO-8102025-08-07
00816465020305NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.NGO-8002025-08-07
00642790600000Scar EsthetiqueScar Heal600002025-04-16
10650551093616NEW BEGINNINGS® GEL SHEETINGPMT CORPORATION3505-12025-03-19
10650551093623NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-102025-03-19
10650551093630NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-112025-03-19
10650551093647NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-122025-03-19
10650551093654NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-22025-03-19
10650551093661NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-32025-03-19
10650551093678NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-42025-03-19
10650551093685NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-52025-03-19
10650551093692NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-82025-03-19
20650551093613NEW BEGINNINGS® GEL SHEETINGPMT CORPORATION3505-1-62025-03-19
20650551093620NEW BEGINNINGS® GELSHAPES®PMT CORPORATION3505-10-62025-03-19
06941917833623LorskiShandong Zhushi Pharmaceutical Group Co., Ltd. First Office3×15cm2024-12-28
06941917833173LorskiShandong Zhushi Pharmaceutical Group Co., Ltd. First Office3×5cm2024-12-17
00197644272952Scarguard® Labs Vitamin E SheetsBlh Pharmaceuticals Inc.None2024-12-03
00383160000036ScarMDAIM MEDICAL INC.15g CN2024-07-15
00383160000043ScarMDAIM MEDICAL INC.15g Glide CN2024-07-15
00383160000050ScarMDAIM MEDICAL INC.6g CN2024-07-15
00383160000067ScarMDAIM MEDICAL INC.3g CN2024-07-15
00383160000074ScarMDAIM MEDICAL INC.1g CN2024-07-15
00383160000081ScarMDAIM MEDICAL INC.6g Glide CN2024-07-15
00860004589785ScarMDAIM MEDICAL INC.6g Glide2024-04-24
00383160000005ScarMDAIM MEDICAL INC.0012024-04-25
00070030511746Kelo-cote Advanced Formula Scar GelAlliance Pharma Inc.Lot Code2024-04-10
00070030511753Kelo-cote Advanced Formula Scar GelAlliance Pharma Inc.Lot Code2024-04-10
00358962203060ScarAway Silicone Scar Gel for KidsAlliance Pharma Inc.Lot Code2024-04-10
00358962203152ScarAway Silicone Acne Scar GelAlliance Pharma Inc.Lot Code2024-04-10
00358962203206ScarAway Silicone Scar GelAlliance Pharma Inc.Lot Code2024-04-10
00358962204104ScarAway Silicone Scar GelAlliance Pharma Inc.Lot Code2024-04-10
10372380000008szosil medical grade silicone sheeting gel for scarsVIVERA PHARMACEUTICALS, INC.12019-08-23