FDA.reportPublic FDA data

R&L Medical

Primary DI
06972949026066
Brand
R&L Medical
Company
Hangzhou R&L Medical Device Co., Ltd
Model
J-12cm×6cm×2pcs
Published
2025-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
06972949026066PackageGS12In Commercial Distribution
16972949026063PackageGS196In Commercial Distribution
86972949026062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972949026066069729490260666972949026066
1697294902606316972949026063
8697294902606286972949026062

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
415588794
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
06972949026097SensifineHD01012025-12-12
06972949026103SensifineHD2025-12-12
16972949026094SensifineHD01012025-12-12
16972949026100SensifineHD2025-12-12
06972949026110SensifineJ-15cm×12cm2025-12-08
06972949026127SensifineSGX0152025-12-08
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
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
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
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