FDA.reportPublic FDA data

Mederma Medical Grade Silicone Scar Sheet Large 4ct

Primary DI
00810000310265
Brand
Mederma Medical Grade Silicone Scar Sheet Large 4ct
Company
HRA PHARMA AMERICA, INC.
Model
00810000310265
Device description
Silicone sheets for scar management
Published
2022-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MDAElastomer, Silicone, For Scar Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDAElastomer, Silicone, For Scar ManagementGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810000310265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000310265008100003102658100003102650810000310265

GMDN Terms#

Term, Definition table
TermDefinition
Scar management dressing, single-use, non-sterileA non-sterile covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel, polyurethane) 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081160441
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810000310258Mederma Medical Grade Silicone Scar Sheet Small 4ct008100003102582022-02-05
00810000318018Compeed Advanced Blister Care Medium 12p008100003180182020-11-17
00810000318025Compeed Advanced Blister Care Sports Mixed 9p (6+3)008100003180252020-11-17
00810000318292Compeed Advanced Blister Care Medium Skin Tone x10008100003182922021-04-20
00810000310371Compeed Advanced Blister Care Mixed 6008100003103712023-02-15
00810000318162Mederma Cold Sore 15ct8100003181622020-10-02
00810000310012Compeed Blister Medium 5p USA008100003100122020-07-04
00810000310036Compeed Blister Mix Pack 5p USA008100003100362020-07-04
00810000310043Compeed Blister Small 6p USA008100003100432020-07-04
00810000310050Compeed Corn Medium 10p USA008100003100502020-07-04
00810000310067Compeed Twin Pack Blister Medium 2x5ct008100003100672020-07-04
00810000310074Compeed Twin Pack Blister Extreme 5p USA008100003100742020-07-04
00810000310081Compeed Twin Pack Blister Mix Pack 2+2+1p USA008100003100812020-07-04
00810000310098Compeed Twin Pack Blister Sml 6p USA008100003100982020-07-04
00810000310104Compeed Twin Pack Corn Med 10p USA008100003101042020-07-04
00810000310111Compeed Twin Pack Blister Sports Medium 8ct008100003101112020-07-04
00810000310128Compeed Twin Pack Blister Sports Mixed 9ct008100003101282020-07-04
00810000310135Compeed Twin Pack Blister High Heel 9ct008100003101352020-07-04
00810000310166Compeed Advanced Blister Care Medium 1p008100003101662020-07-04
00810000310180Compeed Advanced Blister Care High Heel 8p (oyster)008100003101802020-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B490100101Dimisil Scar GelAartMDA2026-06-04
G4207011Silicone for Scar ManagementGottfried Medical, Inc.MDA2026-06-04
G4207101Silicone for Scar ManagementGottfried Medical, Inc.MDA2026-06-04
05000223482589CICA CARESMITH & NEPHEW MEDICAL LIMITEDMDA2026-04-30
05000223502157CICA CARESMITH & NEPHEW MEDICAL LIMITEDMDA2026-04-30
00860015727305KegelStar Port IncMDA2026-04-25
00885914040461RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040478RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040485RolyanPerformance Health Supply, LLCMDA2026-03-20
00358962230806ScarAway Silicone Scar TapeAlliance Pharma Inc.MDA2026-02-19
00850072068770CeladiaBiowound Solutions, Inc.MDA2025-12-18
00850072068787CeladiaBiowound Solutions, Inc.MDA2025-12-18
10850072068777CeladiaBiowound Solutions, Inc.MDA2025-12-18
10850072068784CeladiaBiowound Solutions, Inc.MDA2025-12-18
04719884330269H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884330368H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884333765H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-11
06972949026110SensifineHangzhou R&L Medical Device Co., LtdMDA2025-12-08
16972949026117SensifineHangzhou R&L Medical Device Co., LtdMDA2025-12-08
00816465020008NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020015NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020046NewGel+UV Silicone Gel for Scars + SPF30Newmedical Technology, Inc.MDA2025-08-07
00816465020213Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020220Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020237Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020244Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020299NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020305NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020329NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020336NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07