FDA.reportPublic FDA data

EPI-DERM

Primary DI
00852260000111
Brand
EPI-DERM
Company
Biodermis LLC
Model
FLP-51
Catalog number
FLP-51
Device description
"Natural Fabric Areopexy 2.75"" OD x .75 ID x 5.90"" L (6.9cm OD x 1.9cm ID) 5 Pair"
Published
2020-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003948000EPI-DERM SILICONE GEL SHEETINGBiodermis Corp.2001-01-29MDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852260000111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852260000111008522600001118522600001110852260000111

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
702-260-4466info@biodermis.com

Regulatory Flags#

DUNS number
809650005
Device count
1
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
00850014883270SCAR AID SCCR-120SCCR-1202023-04-18
00850014883287SCAR AIDSCCS-4SCCS-42023-04-18
00850014883171SCAR AIDSCST-USSCST-US2023-03-10
00850014883188SCAR AIDSCST17-USSCST17-US2023-03-10
00850014883195SCAR AIDSCSTSP-USSCSTSP-US2023-03-10
00850014883201SCAR AIDSCSTSP17-USSCSTSP17-US2023-03-10
00768627007078TOPIGELNC TPG-1112NC TPG-11122022-10-10
00768627007085TOPIGELNC TPG-123NC TPG-1232022-10-10
00768627007092TOPIGELNC TPG-146NC TPG-1462022-10-10
00768627007108TOPIGELNC TPG-46NC TPG-462022-10-10
00768627007122TOPIGELNC TPG-1116NC TPG-11162022-10-10
00768627007139TOPIGELNC TPG15461NC TPG154612022-10-10
00768627007146TOPIGELNC TPG 15460SNC TPG 15460S2022-10-10
00850014883126THERAFOAMTRRU-1TRRU-12021-08-13
00850014883133THERAFOAMTRRU-6TRRU-62021-08-13
00854763005839THERAFOAMTRPU-1TRPU-12021-08-13
00854763005846THERAFOAMTRPU-3TRPU-32021-08-13
00854763005853THERAFOAMTRPU-30TRPU-302021-08-13
00854763005983THERAFOAMTRR-6TRR-62021-08-13
00854763005990THERAFOAMTRR-1TRR-12021-08-13

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