FDA.reportPublic FDA data

Scar management dressing, reusable

Definition
A non-sterile covering made of a silicone-based 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 after appropriate cleaning.
GUDID devices
314
Last updated
2024-02-01 09:41:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06974795050011MEDLOTHenan Maidingkang Medical Technology Co., Ltd.4*15cm2024-01-23
06974795050028MEDLOTHenan Maidingkang Medical Technology Co., Ltd.10*18cm2024-01-23
06974795050035MEDLOTHenan Maidingkang Medical Technology Co., Ltd.4cm*4m2024-01-23
06974795050042MEDLOTHenan Maidingkang Medical Technology Co., Ltd.4cm*2m2024-01-23
00373352540013RevivaSil Gel Pad KitTrifluent Pharma, LLC012024-01-22
00810050460347Oleeva Fabric 1.5x3 ACPSBio Med Sciences, Inc.37042023-12-31
00810050460422Oleeva Fabric 2x24 CPSBio Med Sciences, Inc.3748-CPS2023-12-31
00810050460460Oleeva Fabric Abdominoplasty Shape NESSBio Med Sciences, Inc.37AP-NESS2023-12-31
00810050460507Oleeva Fabric Breast Anchor Shape NESSBio Med Sciences, Inc.37BF-NESS2023-12-31
00810050460538Oleeva Fabric Breast Kit NESSBio Med Sciences, Inc.37BK-NESS2023-12-31
00810050460569Oleeva Fabric Brachioplasty Shape NESSBio Med Sciences, Inc.37BP-NESS2023-12-31
00810050460620Oleeva Fabric Vertical Mastopexy Shape NESSBio Med Sciences, Inc.37VM-NESS2023-12-31
10810050460160Oleeva Foam 1.5x5Bio Med Sciences, Inc.32082023-12-31
10810050460177Oleeva Foam 5x5Bio Med Sciences, Inc.32252023-12-31
10810050460184Oleeva Foam 5x10Bio Med Sciences, Inc.32502023-12-31
10810050460191Oleeva Foam 11x12Bio Med Sciences, Inc.32962023-12-31
10810050460207Oleeva Foam Abdominoplasty ShapeBio Med Sciences, Inc.32APS2023-12-31
10810050460214Oleeva Foam Breast Areola ShapeBio Med Sciences, Inc.32BA2023-12-31
10810050460221Oleeva Foam 5.2x2.2Bio Med Sciences, Inc.32BF2023-12-31
10810050460238Oleeva Foam Breast Anchor ShapeBio Med Sciences, Inc.32BFS2023-12-31
10810050460245Oleeva Foam Breast KitBio Med Sciences, Inc.32BKS2023-12-31
10810050460252Oleeva Foam C-SectionBio Med Sciences, Inc.32CS2023-12-31
10810050460269Oleeva Foam Vertical Mastopexy ShapeBio Med Sciences, Inc.32VM2023-12-31
10810050460276Oleeva Clear 1.5x3Bio Med Sciences, Inc.35042023-12-31
10810050460283Oleeva Clear 1.5x5Bio Med Sciences, Inc.35082023-12-31
10810050460290Oleeva Clear 5x5Bio Med Sciences, Inc.35252023-12-31
10810050460306Oleeva Clear 5x10Bio Med Sciences, Inc.35502023-12-31
10810050460313Oleeva Clear 8x12Bio Med Sciences, Inc.35962023-12-31
10810050460320Oleeva Fabric 1.5x3Bio Med Sciences, Inc.37042023-12-31
10810050460375Oleeva Fabric 1.5x5Bio Med Sciences, Inc.37082023-12-31
10810050460382Oleeva Fabric 1.5x7Bio Med Sciences, Inc.37102023-12-31
10810050460399Oleeva Fabric 2x8Bio Med Sciences, Inc.37162023-12-31
10810050460405Oleeva Fabric 5x5Bio Med Sciences, Inc.37252023-12-31
10810050460412Oleeva Fabric 2x24Bio Med Sciences, Inc.37482023-12-31
10810050460436Oleeva Fabric 5x10Bio Med Sciences, Inc.37502023-12-31
10810050460443Oleeva Fabric 8x12Bio Med Sciences, Inc.37962023-12-31
10810050460450Oleeva Fabric Abdominoplasty ShapeBio Med Sciences, Inc.37AP2023-12-31
10810050460474Oleeva Fabric Abdominoplasty Shape (SMALL)Bio Med Sciences, Inc.37APS2023-12-31
10810050460481Oleeva Fabric Breast AreolaBio Med Sciences, Inc.37BA2023-12-31
10810050460498Oleeva Fabric Breast Anchor ShapeBio Med Sciences, Inc.37BF2023-12-31
10810050460511Oleeva Fabric Breast Anchor Shape SMALLBio Med Sciences, Inc.37BFS2023-12-31
10810050460528Oleeva Fabric Breast KitBio Med Sciences, Inc.37BK2023-12-31
10810050460542Oleeva Fabric Breast Kit SMALLBio Med Sciences, Inc.37BKS2023-12-31
10810050460559Oleeva Fabric Brachioplasty ShapeBio Med Sciences, Inc.37BP2023-12-31
10810050460573Oleeva Fabric C-Section ShapeBio Med Sciences, Inc.37CS2023-12-31
10810050460580Oleeva Fabric Cardiothoracic ShapeBio Med Sciences, Inc.37CTS2023-12-31
10810050460597Oleeva Fabric Thyroid ShapeBio Med Sciences, Inc.37TH2023-12-31
10810050460603Oleeva Fabric Umbilicoplasty ShapeBio Med Sciences, Inc.37UM2023-12-31
10810050460610Oleeva Fabric Vertical Mastopexy ShapeBio Med Sciences, Inc.37VM2023-12-31
10810050460634Silon-STS 16x21x1/16Bio Med Sciences, Inc.43362023-12-31
10810050460641Silon-LTS 9x12Bio Med Sciences, Inc.46082023-12-31
10810050460658Silon-LTS 12x18Bio Med Sciences, Inc.47162023-12-31
04026275447476Amoena AMOENA Medizin-Orthopädie-Technik GmbH010 Strips (04)2023-08-17
04026275447544Amoena AMOENA Medizin-Orthopädie-Technik GmbH011 Squares2023-08-17
04026275447551Amoena AMOENA Medizin-Orthopädie-Technik GmbH012 Mammilla Circles2023-08-17
04026275447568Amoena AMOENA Medizin-Orthopädie-Technik GmbH013 Anchors2023-08-17
04026275484846Amoena AMOENA Medizin-Orthopädie-Technik GmbH010 Strips (01)2023-08-17
10852869005002SCARFADEHanson Medical, Inc.051106-42023-07-19
00852869005197SCARFADE EliteHanson Medical, Inc.021907-122023-07-19
10852869005019SCARFADEHanson Medical, Inc.051106-42023-07-19
10852869005026SCARFADEHanson Medical, Inc.051106-42023-07-19
10852869005033SCARFADE CHanson Medical, Inc.031606-52023-07-19
00850014883270SCAR AID Biodermis LLCSCCR-1202023-04-18
00850014883287SCAR AIDBiodermis LLCSCCS-42023-04-18
00850014883171SCAR AIDBiodermis LLCSCST-US2023-03-10
00850014883188SCAR AIDBiodermis LLCSCST17-US2023-03-10
00850014883195SCAR AIDBiodermis LLCSCSTSP-US2023-03-10
00850014883201SCAR AIDBiodermis LLCSCSTSP17-US2023-03-10
00642790101019Scar FxScar Heal101012022-12-06
M724CSG051Cimeosil® Scar and Laser GelIMPLANTECH ASSOCIATES, INC.5 gram2020-05-27
M724CSG141Cimeosil® Scar and Laser GelIMPLANTECH ASSOCIATES, INC.14 gram2020-05-27
00768627007078TOPIGELBiodermis LLCNC TPG-11122022-10-10
00768627007085TOPIGELBiodermis LLCNC TPG-1232022-10-10
00768627007092TOPIGELBiodermis LLCNC TPG-1462022-10-10
00768627007108TOPIGELBiodermis LLCNC TPG-462022-10-10
00768627007122TOPIGELBiodermis LLCNC TPG-11162022-10-10
00768627007139TOPIGELBiodermis LLCNC TPG154612022-10-10
00768627007146TOPIGELBiodermis LLCNC TPG 15460S2022-10-10
04719745504525Anscare LeniScar Silicone StickBENQ MATERIALS CORP.SP-200-12022-09-19
04719745505058Anscare LeniScar Silicone StickBENQ MATERIALS CORP.SP-200-22022-09-19