Bactine Antimicrobial Wound Care Hydrogel 86043

GUDID 20365197851106

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID20365197851106
NIH Device Record Key2883a086-5d79-4278-8e50-0cec64ea8cf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBactine Antimicrobial Wound Care Hydrogel
Version Model Number86043
Catalog Number86043
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 Producttrue
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

Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram
Weight227 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100365197851102 [Primary]
GS110365197851109 [Package]
Package: Case [8 Units]
In Commercial Distribution
GS120365197851106 [Package]
Contains: 00365197851102
Package: Box [3 Units]
In Commercial Distribution

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-30
Device Publish Date2025-07-22

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

20365197504002 - Solarcaine Advanced Burn Relief Hydrogel2025-07-30
20365197851106 - Bactine Antimicrobial Wound Care Hydrogel2025-07-30
20365197851106 - Bactine Antimicrobial Wound Care Hydrogel2025-07-30
10850015491839 - PhaseOne Antimicrobial Solution2025-07-18
10860009268606 - PhaseOne Antimicrobial Solution2025-07-18
00860009268616 - PhaseOne Antimicrobial Solution2025-07-18
10365197409300 - A+D Antimicrobial Hydrogel Spray2025-06-18
20198715994272 - Advanced Scar & Wound Hydrogel2025-05-15
20850015491782 - Rejuvacyn Plus Dermal Spray2025-05-15

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