FDA.reportPublic FDA data

Scar Esthetique

Primary DI
00642790600000
Brand
Scar Esthetique
Company
Scar Heal
Model
60000
Catalog number
60000
Device description
Scar Esthetique Scar Creme with Silicone 60ml
Published
2025-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00642790600000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642790600000006427906000006427906000000642790600000

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume60Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit80.6 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
727-535-0022hello@rejuvaskin.com

Regulatory Flags#

DUNS number
014302733
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642790101019Scar Fx10101101012022-12-06
00642790100005Scar Fx10000100002020-07-31
00642790101125Scar Fx10112101122020-07-31
00642790101224Scar Fx10122101222020-07-31
00642790103051Scar Fx10305103052020-07-31
00642790104089Scar Fx 10408104082020-07-31
00642790106489Scar Fx10648106482020-07-31
00642790110127Scar Fx11012110122020-07-31
00642790112343Scar Fx11234112342020-07-31
00642790115030Scar Fx11503115032020-07-31
00642790115054Scar Fx11505115052020-07-31
00642790115092Scar Fx11509115092020-07-31
00642790134567Scar Fx13456134562020-07-31
00642790156781Scar Fx15678156782020-07-31
00642790800004RejuvaSil 80000800002020-07-31
00642790800103RejuvaSil80010800102020-07-31
00642790800158RejuvaSil80015800152020-07-31
00642790850009ScarSil85000850002020-07-31
00642790850153ScarSil85015850152020-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00816465020343NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020350NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020367Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07