FDA.reportPublic FDA data

Granudacyn

Primary DI
09120073781581
Brand
Granudacyn
Company
P.G.F. Industry Solutions GmbH
Model
360170
Device description
Granudacyn Wound Wash Solution, Spray, 250 ml US
Published
2026-02-10
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
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
09120073781581PackageGS11In Commercial Distribution
09120073781635PackageGS115In Commercial Distribution
09120073781536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073781581091200737815819120073781581
09120073781635091200737816359120073781635
09120073781536091200737815369120073781536

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, multiple soluteA solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and 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
301349382
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
09120073781536Granudacyn3601702026-02-10
09120073781543Granudacyn3601712026-02-10
09120073781550Granudacyn3601722026-02-10
09120073781567Granudacyn3601732026-02-10
09120073781574Granudacyn3601742026-02-10
09120073781598Granudacyn3601712026-02-10
09120073781604Granudacyn3601722026-02-10
09120073781611Granudacyn3601732026-02-10
09120073781628Granudacyn3601742026-02-10

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