Advanced Scar & Wound Hydrogel 86040

GUDID 20198715994272

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID20198715994272
NIH Device Record Key9a53402c-82f9-44f7-b6d9-df9ee3450f62
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Scar & Wound Hydrogel
Version Model Number86040
Catalog Number86040
Company DUNS081642964
Company NameSonoma Pharmaceuticals, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram
Weight56 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100198715994278 [Primary]
GS120198715994272 [Package]
Contains: 00198715994278
Package: Box [24 Units]
In Commercial Distribution

FDA Product Code

PFPSilicone Hydrogel For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-15
Device Publish Date2025-05-07

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

20198715994272 - Advanced Scar & Wound Hydrogel2025-05-15
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20365197409000 - A+D Antimicrobial Hydrogel Spray2025-04-14
20850015491751 - Ocucyn Eyelid & Eyelash Cleanser2024-09-12
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