FDA.reportPublic FDA data

Huibo Medical

Primary DI
06936943404022
Brand
Huibo Medical
Company
Henan Huibo Medical Co.,Ltd.
Model
15g
Device description
medical polymer materials imported from USApolymer gel- biological adhesion gel imported from overseas.hydrogel matrix-fine and smooth. Proper consistency and thickness; do not pollute clothing and easy to cleaning for non-greasy; odourless and colorless, can inject quickly into the skin by rubbing. a thin transparent film which is breathable and waterproof can be formed after applying this product to the scar. Not only ensure breath to the skin, but also promote metabolize and lock water to soft scar and eliminate discomfort. Effect of relieving itching.
Published
2020-01-21
Public version status
Update
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
06936943404022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936943404022069369434040226936943404022

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

Regulatory Flags#

DUNS number
560455084
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
06936943403087Huibo Medical4*30cm2020-02-26
06936943403094Huibo Medical12*15cm2020-02-26
06936943404039Huibo Medical25g2020-02-28
06936943403100Huibo Medical6cm*8cm2020-01-20
06936943411136Huibo Medical10*10cm2020-01-21
06936943411150Huibo Medical10cm*10cm2020-01-21
06936943411471Huibo Medical10*10cm2020-01-21
06936943411488Huibo Medical10*10cm2020-01-21
06936943400598Huibo Medical10*10cm, border2020-01-21
06936943412416Huibo Medical10*10cm, borderless2020-01-21
06936943411839Huibo MedicalI-AD-S, open toe, beige2020-02-28
06936943411846Huibo MedicalI-AD-M, Beige, Open toe2020-02-28
06936943411853Huibo MedicalI-AD-L, Beige, Open toe2020-02-26
06936943472175Huibo MedicalII-AD-M2020-01-21
06936943403070Huibo Medical4*30cm2020-02-26
06936943403063Huibo Medical12*15cm2020-02-26
06936943411457Huibo Medical25*10mm2020-02-26

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