ELECTROCYN soma

Primary DI
09551012610028
Brand
ELECTROCYN soma
Company
V3BIO SDN. BHD.
Model
ES3300W
Catalog number
ES3300W
Device description
ELECTROCYN soma is a medical device under category of wound wash and irrigation solution. The solution contains 99.9% purified water and with combined percentage of not more than 0.1% of Hypochlorous acid (HOCl) + Sodium hypochlorite (NaOCl) + sodium chloride (NaCl) which are produced by electrolysis technology with the use of purified water and purified salt. The primary intention of the ELECTROCYN soma solution is for mechanical debridement, irrigation, and moistening. The mechanical action of irrigating and debriding would assist in removing dead, damaged and contaminated tissues on and around the wound.
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

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
09551012610028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551012610028095510126100289551012610028

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
659301481
Device count
1
DM exempt
false
Premarket exempt
true
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
09551012610035ELECTROCYN somaES4300WES4300W2026-04-02
09551012610196ELECTROCYN somaES5400WES5400W2026-04-02
09551012610363ELECTROCYN somaES5110WES5110W2026-04-02
09551012610370ELECTROCYN somaES4110WES4110W2026-04-02
09551012610066ELECTROCYN somaES7100WES7100W2024-12-06
09551012610042ELECTROCYN somaES4100WES4100W2023-09-01
09551012610059ELECTROCYN somaES5100WES5100W2023-09-01
09551012610295ELECTROCYN somaES4400WES4400W2023-09-01
09551012610318ELECTROCYN somaES1300WES1300W2023-09-01
09551012610325ELECTROCYN soma (nurodermis)ES1301WES1301W2024-02-26
09551012610332ELECTROCYN soma (nurodermis)ES3301WES3301W2024-02-26

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09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
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