FDA.reportPublic FDA data

Nixall Antimicrobial Solutions

Primary DI
00851608007539
Brand
Nixall Antimicrobial Solutions
Company
Seriously Clean, Ltd.
Model
221Z1
Device description
Wound & Skin Hydrogel OTC
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851608007539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851608007539008516080075398516080075390851608007539

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020333292
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851608007546Nixall Antimicrobial Solutions222Z12025-05-12
00851608007201Nixall211F1L2023-03-09
00851608007218Nixall811F1L2023-03-09
00851608007225Nixall211M1L2023-03-09
00851608007232Nixall811M1L2023-03-09

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