FDA.reportPublic FDA data

ScarAway Silicone Scar Gel

Primary DI
00358962204104
Brand
ScarAway Silicone Scar Gel
Company
Alliance Pharma Inc.
Model
Lot Code
Device description
ScarAway Silicone Scar Gel Tube 10g Single CA
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00358962204104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00358962204104003589622041043589622041040358962204104

GMDN Terms#

Term, Definition table
TermDefinition
Scar-management dressing, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081138954
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00358962230806ScarAway Silicone Scar TapeLot Code2026-02-19
00358962203008ScarAway Silicone Scar Sheets Variety PackLot Code2024-04-23
00358962203305ScarAway Silicone Clear Scar SheetsLot Code2024-04-23
00358962203404ScarAway Silicone Clear Scar SheetsLot Code2024-04-23
00358962203503ScarAway Silicone Scar Sheets for C-SectionsLot Code2024-04-23
00358962203602ScarAway Silicone Scar SheetsLot Code2024-04-23
00358962203688ScarAway Silicone Scar SheetsLot Code2024-04-23
00358962203701ScarAway Silicone Scar Sheets & Scar Gel Complete Scar Treatment KitLot Code2024-04-23
00070030511746Kelo-cote Advanced Formula Scar GelLot Code2024-04-10
00070030511753Kelo-cote Advanced Formula Scar GelLot Code2024-04-10
00358962203060ScarAway Silicone Scar Gel for KidsLot Code2024-04-10
00358962203152ScarAway Silicone Acne Scar GelLot Code2024-04-10
00358962203206ScarAway Silicone Scar GelLot Code2024-04-10
00358962203107ScarAway Silicone Scar GelLot Code2024-04-09
00358962302008Canker-X Rincinol Mouth Sore RinseLot Code2024-04-05
00358962303005Canker-X Mouth Sore SprayLot Code2024-04-05
00358962301001Canker-X Mouth Sore GelLot Code2024-04-02

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