FDA.reportPublic FDA data

Scar Fx

Primary DI
00642790100005
Brand
Scar Fx
Company
Scar Heal
Model
10000
Catalog number
10000
Device description
"Scar Fx Silicone Sheeting 3"" Breast Circle"
Published
2020-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00642790240008PackageGS12In Commercial Distribution
00642790100005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642790240008006427902400086427902400080642790240008
00642790100005006427901000056427901000050642790100005

GMDN Terms#

Term, Definition table
TermDefinition
Scar management dressing, reusableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width3Inch

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
00642790600000Scar Esthetique60000600002025-04-16
00642790101019Scar Fx10101101012022-12-06
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