FDA.reportPublic FDA data

Sensifine

Primary DI
06972949026127
Brand
Sensifine
Company
Hangzhou R&L Medical Device Co., Ltd
Model
SGX015
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PFPSilicone Hydrogel For Scar Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFPSilicone Hydrogel For Scar ManagementGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972949026124PackageGS1300In Commercial Distribution
06972949026127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697294902612416972949026124
06972949026127069729490261276972949026127

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
415588794
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972949026097SensifineHD01012025-12-12
06972949026103SensifineHD2025-12-12
16972949026094SensifineHD01012025-12-12
16972949026100SensifineHD2025-12-12
06972949026110SensifineJ-15cm×12cm2025-12-08
16972949026117SensifineJ-15cm×12cm2025-12-08
16972949026124SensifineSGX0152025-12-08
86972949026031R&L MedicalJ-12cm×3cm2025-04-22
86972949026048R&L MedicalJ-12cm×3cm×2pcs2025-04-22
86972949026055R&L MedicalJ-12cm×6cm2025-04-22
86972949026062R&L MedicalJ-12cm×6cm×2pcs2025-04-22
86972949026079R&L MedicalJ-15cm×12cm2025-04-22
86972949026086R&L MedicalJ-15cm×12cm×2pcs2025-04-22
06972949026035R&L MedicalJ-12cm×3cm2025-04-22
06972949026042R&L MedicalJ-12cm×3cm×2pcs2025-04-22
06972949026059R&L MedicalJ-12cm×6cm2025-04-22
06972949026066R&L MedicalJ-12cm×6cm×2pcs2025-04-22
06972949026073R&L MedicalJ-15cm×12cm2025-04-22
06972949026080R&L MedicalJ-15cm×12cm×2pcs2025-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015727312KegelStar Port IncPFP2026-04-27
16972949026124SensifineHangzhou R&L Medical Device Co., LtdPFP2025-12-08
00850015491870Aquanil Recovery GelSonoma Pharmaceuticals, Inc.PFP2025-11-04
06974795051940MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-08-13
06974795055580MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-08-13
06974795059861MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-08-13
06974795053371MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-07-29
06974795057508MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-07-29
06974795056242MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-06-12
06974795052107MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-06-11
06974795053258MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-06-11
00198715994278Advanced Scar & Wound HydrogelSonoma Pharmaceuticals, Inc.PFP2025-05-07
20198715994272Advanced Scar & Wound HydrogelSonoma Pharmaceuticals, Inc.PFP2025-05-07
86972949026031R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
86972949026048R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
86972949026055R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
86972949026062R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
86972949026079R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
86972949026086R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
06972949026035R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
06972949026042R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
06972949026059R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
06972949026066R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
06972949026073R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
06972949026080R&L MedicalHangzhou R&L Medical Device Co., LtdPFP2025-04-22
06974795058239MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-04-01
06974795054538MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-03-07
06974795051971MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2025-02-07
06974795055320MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2024-12-20
06974795052688MEDLOTHenan Maidingkang Medical Technology Co., Ltd.PFP2024-12-19