FDA.reportPublic FDA data

Scar-management dressing, reusable

Definition
A covering 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 an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.
GUDID devices
208
Last updated
2026-07-28 06:05:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05060551222004Medi GradeFBGC LIMITEDMG-SKN-SSR012026-07-17
06970206823960Dr Perfect Silicone Scar SheetsJiangsu NewValue Medical Products Co.,Ltd./2026-06-22
06970206823984kegel Silicone Scar SheetsJiangsu NewValue Medical Products Co.,Ltd./2026-06-22
B490100101Dimisil Scar GelAartA2026-06-04
G4207011Silicone for Scar ManagementGottfried Medical, Inc.7012026-06-04
G4207101Silicone for Scar ManagementGottfried Medical, Inc.7102026-06-04
G420701Silicone for Scar ManagementGottfried Medical, Inc.7012023-08-15
G420710Silicone for Scar ManagementGottfried Medical, Inc.7102023-08-15
00810050460163Oleeva Foam 1.5x5Bio Med Sciences, Inc.32082023-12-31
00810050460170Oleeva Foam 5x5Bio Med Sciences, Inc.32252023-12-31
00810050460187Oleeva Foam 5x10Bio Med Sciences, Inc.32502023-12-31
00810050460194Oleeva Foam 11x12Bio Med Sciences, Inc.32962023-12-31
00810050460200Oleeva Foam Abdominoplasty ShapeBio Med Sciences, Inc.32APS2023-12-31
00810050460217Oleeva Foam Breast Areola ShapeBio Med Sciences, Inc.32BA2023-12-31
00810050460224Oleeva Foam 5.2x2.2Bio Med Sciences, Inc.32BF2023-12-31
00810050460231Oleeva Foam Breast Anchor ShapeBio Med Sciences, Inc.32BFS2023-12-31
00810050460248Oleeva Foam Breast KitBio Med Sciences, Inc.32BKS2023-12-31
00810050460255Oleeva Foam C-SectionBio Med Sciences, Inc.32CS2023-12-31
00810050460262Oleeva Foam Vertical Mastopexy ShapeBio Med Sciences, Inc.32VM2023-12-31
00810050460279Oleeva Clear 1.5x3Bio Med Sciences, Inc.35042023-12-31
00810050460286Oleeva Clear 1.5x5Bio Med Sciences, Inc.35082023-12-31
00810050460293Oleeva Clear 5x5Bio Med Sciences, Inc.35252023-12-31
00810050460309Oleeva Clear 5x10Bio Med Sciences, Inc.35502023-12-31
00810050460316Oleeva Clear 8x12Bio Med Sciences, Inc.35962023-12-31
00810050460323Oleeva Fabric 1.5x3Bio Med Sciences, Inc.37042023-12-31
00810050460378Oleeva Fabric 1.5x5Bio Med Sciences, Inc.37082023-12-31
00810050460385Oleeva Fabric 1.5x7Bio Med Sciences, Inc.37102023-12-31
00810050460392Oleeva Fabric 2x8Bio Med Sciences, Inc.37162023-12-31
00810050460408Oleeva Fabric 5x5Bio Med Sciences, Inc.37252023-12-31
00810050460415Oleeva Fabric 2x24Bio Med Sciences, Inc.37482023-12-31
00810050460439Oleeva Fabric 5x10Bio Med Sciences, Inc.37502023-12-31
00810050460446Oleeva Fabric 8x12Bio Med Sciences, Inc.37962023-12-31
00810050460453Oleeva Fabric Abdominoplasty ShapeBio Med Sciences, Inc.37AP2023-12-31
00810050460477Oleeva Fabric Abdominoplasty Shape (SMALL)Bio Med Sciences, Inc.37APS2023-12-31
00810050460484Oleeva Fabric Breast AreolaBio Med Sciences, Inc.37BA2023-12-31
00810050460491Oleeva Fabric Breast Anchor ShapeBio Med Sciences, Inc.37BF2023-12-31
00810050460514Oleeva Fabric Breast Anchor Shape SMALLBio Med Sciences, Inc.37BFS2023-12-31
00810050460521Oleeva Fabric Breast KitBio Med Sciences, Inc.37BK2023-12-31
00810050460545Oleeva Fabric Breast Kit SMALLBio Med Sciences, Inc.37BKS2023-12-31
00810050460552Oleeva Fabric Brachioplasty ShapeBio Med Sciences, Inc.37BP2023-12-31
00810050460576Oleeva Fabric C-Section ShapeBio Med Sciences, Inc.37CS2023-12-31
00810050460583Oleeva Fabric Cardiothoracic ShapeBio Med Sciences, Inc.37CTS2023-12-31
00810050460590Oleeva Fabric Thyroid ShapeBio Med Sciences, Inc.37TH2023-12-31
00810050460606Oleeva Fabric Umbilicoplasty ShapeBio Med Sciences, Inc.37UM2023-12-31
00810050460613Oleeva Fabric Vertical Mastopexy ShapeBio Med Sciences, Inc.37VM2023-12-31
00810050460637Silon-STS 16x21x1/16Bio Med Sciences, Inc.43362023-12-31
00810050460644Silon-LTS 9x12Bio Med Sciences, Inc.46082023-12-31
00810050460651Silon-LTS 12x18Bio Med Sciences, Inc.47162023-12-31
00810113576756ViveCareVIVE HEALTH LLCRHB3022BGEM2024-08-20
00814639025484Wound FreeAPPLIED DENTAL, INC.SCS-T1R2022-05-20
00814639025491Wound FreeAPPLIED DENTAL, INC.SCS-T5R2022-05-20
00850072068770CeladiaBiowound Solutions, Inc.SS150120-122025-12-18
00850072068787CeladiaBiowound Solutions, Inc.SS074044O-182025-12-18
00852869005005SCARFADEHanson Medical, Inc.051106-42023-07-19
00852869005012SCARFADEHanson Medical, Inc.051106-42023-07-19
00852869005029SCARFADEHanson Medical, Inc.051106-42023-07-19
00852869005036SCARFADE CHanson Medical, Inc.031606-52023-07-19
00852869005173SCARFADE EliteHanson Medical, Inc.021907-122023-07-19
00860015727305KegelStar Port IncSC-032026-04-25
00860015727312KegelStar Port IncSG-032026-04-27
05000223441579CICA-CARE 15CM X 12CMSMITH & NEPHEW MEDICAL LIMITED66250706, 662507072021-02-12
05000223441586CicaCare 12cm x 6cm Ctn of 1 GlobalSMITH & NEPHEW MEDICAL LIMITED662507042021-02-12
05060247395050Optiheal Silicone Wound Recovery StripsNeo G USA IncAW0052021-01-19
06936943403087Huibo MedicalHenan Huibo Medical Co.,Ltd.4*30cm2020-02-26
06936943403094Huibo MedicalHenan Huibo Medical Co.,Ltd.12*15cm2020-02-26
06972949026110SensifineHangzhou R&L Medical Device Co., LtdJ-15cm×12cm2025-12-08
06972949026127SensifineHangzhou R&L Medical Device Co., LtdSGX0152025-12-08
06974600043689KONLIDASuzhou Konlida Medical Supplies Co., Ltd.BHT08-B 15×3cm2025-07-28
14711182607002Rystora® Scar SheetsFORTUNE MEDICAL INSTRUMENT CORP.SA0425122021-12-13
14711182607019Rystora® Scar SheetsFORTUNE MEDICAL INSTRUMENT CORP.SA0507122021-12-13
14711182607026Rystora® Scar SheetsFORTUNE MEDICAL INSTRUMENT CORP.SA1018122021-12-13
14711182608153Rystora Silicone Scar GelFORTUNE MEDICAL INSTRUMENT CORP.SGA015012021-12-30
15060295490001SilDerm Scar SpraySKINGEN UK LTD10ml2020-08-31
15060295490032SilDerm Scar Gel SKINGEN UK LTD15g2020-08-31
15060295490056SilDerm Scar GelSKINGEN UK LTD6g2020-08-31
15060295490094SilDerm Scar SpraySKINGEN UK LTD30ml2020-08-31
15060295490100SilDerm Scar SpraySKINGEN UK LTD60ml2020-08-31
15060295491220SilDerm Scar Gel SachetSKINGEN UK LTD3g2020-08-31
86972949026031R&L MedicalHangzhou R&L Medical Device Co., LtdJ-12cm×3cm2025-04-22
86972949026048R&L MedicalHangzhou R&L Medical Device Co., LtdJ-12cm×3cm×2pcs2025-04-22