FDA.reportPublic FDA data

NA

Primary DI
06974795050141
Brand
NA
Company
Henan Maidingkang Medical Technology Co., Ltd.
Model
Non-Sterile
Device description
Scar Sticker (Non-Sterile)
Published
2022-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
16974795050148PackageGS110In Commercial Distribution
06974795050141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697479505014816974795050148
06974795050141069747950501416974795050141

GMDN Terms#

Term, Definition table
TermDefinition
Scar-management dressing, single-useA covering/substance 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 a flexible or elastic sheet/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). After application, this device cannot be reused.

Regulatory Flags#

DUNS number
724981491
Device count
1
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
06974795059106MEDLOT44*69mm+37*55mm+42*45mm+41*62mm+21*65mm+18*61mm+202026-05-06
06974795059540MEDLOT44*69mm+37*55mm+42*45mm+41*62mm+21*65mm+18*61mm+202026-05-06
06974795053920MEDLOT10*10cm2026-03-13
06974795054392MEDLOT5cm*4.88m2026-01-06
06974795059120MEDLOT10*10cm2025-10-09
06974795053142MEDLOT15*15cm2025-09-29
06974795055474MEDLOT15*15cm2025-09-29
06974795056341MEDLOT5cm*4.88m2025-08-22
06974795057256MEDLOT5cm*3.66m2025-08-22
06974795058314MEDLOT5cm*3.66m2025-08-22
06974795051940MEDLOT4cm*2m2025-08-13
06974795055580MEDLOT4cm*2m2025-08-13
06974795059861MEDLOT4cm*4m2025-08-13
06974795057119MEDLOT10*10cm2025-08-04
06974795058864MEDLOT10*10cm2025-08-04
06974795056150MEDLOT15*15cm2025-08-01
06974795053371MEDLOT10*18cm2025-07-29
06974795057508MEDLOT4*15cm2025-07-29
06974795056242MEDLOT4*15cm2025-06-12
06974795052107MEDLOT10*18cm2025-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015727312KegelStar Port IncPFP2026-04-27
06972949026127SensifineHangzhou R&L Medical Device Co., LtdPFP2025-12-08
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