Bactine Antimicrobial Hydrogel Spray 85100

GUDID 10365197851000

Sonoma Pharmaceuticals, Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID10365197851000
NIH Device Record Key246f355d-0111-4957-bedf-645163bad72f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBactine Antimicrobial Hydrogel Spray
Version Model Number86045
Catalog Number85100
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100365197851003 [Primary]
GS110365197851000 [Package]
Contains: 00365197851003
Package: Box [12 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 Date2026-01-26
Device Publish Date2026-01-16

Devices Manufactured by Sonoma Pharmaceuticals, Inc.

10365197851000 - Bactine Antimicrobial Hydrogel Spray 2026-01-26
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20365197409406 - A+D Gentle Face Relief2025-12-02
20365197504101 - Solarcaine Advanced Burn Relief Hydrogel2025-09-15
20365197504002 - Solarcaine Advanced Burn Relief Hydrogel2025-07-30
20365197851106 - Bactine Antimicrobial Wound Care Hydrogel2025-07-30
10850015491839 - PhaseOne Antimicrobial Solution2025-07-18
10860009268606 - PhaseOne Antimicrobial Solution2025-07-18

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