FDA.reportPublic FDA data

Anscare Scar Reduction Silicone Gel C+

Primary DI
14719745503006
Brand
Anscare Scar Reduction Silicone Gel C+
Company
BENQ MATERIALS CORP.
Model
SC201-1
Device description
Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and new scars like keloids and hypertrophic scars resulting from surgery, trauma, burns, etc. (External Use Only)
Published
2022-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
14719745503006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1471974550300614719745503006

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
657476292
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719745027055DermaAngel Acne patchAP-362-c2022-09-21
04719745040429DermaAngel Acne patchAP-361-42022-09-21
04719745053085DermaAngel Acne patchAP-341-52022-09-21
04719745053580DermaAngel Acne patchAP-3c1-j2022-09-21
04719745072628DermaAngel Acne patchAP-361-62022-09-21
04719745108518DermaAngel Active Patch Original AP-361-82022-09-21
04719745108525DermaAngel Active Patch Original AP-391-j2022-09-21
04719745108532DermaAngel Active Patch Original AP-391-82022-09-21
04719745108549DermaAngel Active Patch IntensiveAP-SA151-f2022-09-21
04719745108556DermaAngel Active Patch IntensiveAP-SA151-p2022-09-21
04719745077562DermaAngel Clear Patch OriginalAP-361-c2023-10-11
04719745106682DermaAngel Clear Patch IntensiveAP-SA151-82025-06-24
04719745091568Ameda ComfortGel Hydrogel Pads17261M2025-01-21
04719745091551DermaAngel Clear Patch IntensiveAP-SA1i1-s2024-08-06
04719745053450DermaAngel Clear Patch OriginalAP-361-32024-07-08
04719745073793DermaAngel Clear Patch IntensiveAP-SA151-62024-07-08
04719745088803DermaAngel Clear Patch IntensiveAP-SA1i1-t2024-07-08
04719745088810DermaAngel Clear Patch IntensiveAP-SA1l1-f2024-07-08
04719745088827DermaAngel Clear Patch IntensiveAP-SA1y1-h2024-07-08
04719745074158DermaAngel Clear Patch IntensiveAP-SA101-22024-06-04

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