FDA.reportPublic FDA data

Advanced Scar & Wound Hydrogel

Primary DI
20198715994272
Brand
Advanced Scar & Wound Hydrogel
Company
Sonoma Pharmaceuticals, Inc.
Model
86040
Catalog number
86040
Published
2025-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
20198715994272PackageGS124In Commercial Distribution
00198715994278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019871599427220198715994272
00198715994278001987159942781987159942780198715994278

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight56Gram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081642964
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00365197409105A+D Antimicrobial Hydrogel86034409102026-05-25
00365197851003Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
10365197851000Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
00365197409204A+D Hydrogel Spray Advanced Dermatitis Care86046409202025-11-24
00365197409402A+D Gentle Face Relief86049409402025-11-24
20365197409208A+D Hydrogel Spray Advanced Dermatitis Care86046409202025-11-24
20365197409406A+D Gentle Face Relief86049409402025-11-24
00850015491849Aquanil Repair Mist86050860502025-11-04
00850015491856Aquanil Repair Mist86051860512025-11-04
00850015491863Aquanil Rescue Serum86052860522025-11-04
00850015491870Aquanil Recovery Gel86053860532025-11-04
00850015491900Myze The Spray86057860572025-11-04
00365197760008Intimate Skin Cleansing Spray86048760002025-10-08
00365197760107Bikini Skin Soothing Gel86047760102025-10-08
00365197504107Solarcaine Advanced Burn Relief Hydrogel50410504102025-09-05
20365197504101Solarcaine Advanced Burn Relief Hydrogel50410504102025-09-05
00365197504008Solarcaine Advanced Burn Relief Hydrogel86035860352025-07-22
00365197851102Bactine Antimicrobial Wound Care Hydrogel86043860432025-07-22
20365197504002Solarcaine Advanced Burn Relief Hydrogel86035860352025-07-22
20365197851106Bactine Antimicrobial Wound Care Hydrogel86043860432025-07-22

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
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