FDA.reportPublic FDA data

kegel Silicone Scar Sheets

Primary DI
06970206823984
Brand
kegel Silicone Scar Sheets
Company
Jiangsu NewValue Medical Products Co.,Ltd.
Model
/
Device description
1pc/ bag, 5bags/box, 50boxes/case
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
16970206823981PackageGS150In Commercial Distribution
06970206823984PrimaryGS10
26970206823988Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697020682398116970206823981
06970206823984069702068239846970206823984
2697020682398826970206823988

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.

Regulatory Flags#

DUNS number
544401775
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970206829191PreviClear Border Sacrum Transparent Gel DressingBorder2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingBorder2026-06-23
06970206820808kegel Hydrogel DressingIsland2026-06-22
06970206822390Rhino Rescue Hemostatic Dressing/2026-06-22
06970206823946Dr Perfect Hydrocolloid DressingIsland2026-06-22
06970206823960Dr Perfect Silicone Scar Sheets/2026-06-22
06970206823977kegel Hydrocolloid DressingIsland2026-06-22
06970206827067Ourmed Foam DressingBorder2026-06-22
06970206827074Ourmed Foam DressingBorder2026-06-22
06970206827081Ourmed Foam DressingBorder2026-06-22
06970206827098Ourmed Foam DressingBorder2026-06-22
06970206827104Ourmed Foam DressingBorder2026-06-22
06970206827845SURESPOT Hemostatic Dressing/2026-06-22
06970206828149Ourmed Foam DressingBorder2026-06-22
06970206828156Ourmed Foam DressingBorder2026-06-22
06970206828163Ourmed Foam DressingBorder2026-06-22
06970206828170Ourmed Foam DressingBorder2026-06-22
06970206828217SURESPOT Hemostatic Dressing/2026-06-22
06970206828224SURESPOT Hemostatic Dressing/2026-06-22
06970206823830Hydrocolloid DressingStandard2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970206823960Dr Perfect Silicone Scar SheetsJiangsu NewValue Medical Products Co.,Ltd.MDA2026-06-22
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