FDA.reportPublic FDA data

Recedo Topical Gel

Primary DI
00381811000060
Brand
Recedo Topical Gel
Company
Resilia Pharmaceuticals, Inc.
Model
1
Device description
Recedo Topical Gel is an advanced formula scar gel intended for the management of old and new hypertrophic or keloid scarring resulting from burns, general surgical procedures, or trauma wounds.
Published
2024-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10381811000067PackageGS11In Commercial Distribution
00381811000060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038181100006710381811000067
00381811000060003818110000603818110000600381811000060

GMDN Terms#

Term, Definition table
TermDefinition
Scar-management dressing, reusableA covering 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 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight20Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
404-446-1391mleone@resiliapharma.com

Regulatory Flags#

DUNS number
117711487
Device count
1
DM exempt
true
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
00381811000008Neosalus Cream12024-06-13
00381811000022Neosalus Lotion12024-06-13

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