AccessGUDID - DEVICE: ELECTROCYN soma (09551012610028)

GUDID

Device Identifier (DI) Information

Brand Name: ELECTROCYN soma
Version or Model: ES3300W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES3300W
Company Name: V3BIO SDN. BHD.

Primary DI Number: 09551012610028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 659301481 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59523	Antimicrobial wound irrigation solution	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 100 Milliliter

Device Record Status

Public Device Record Key: bcb7f1d9-79ca-450f-8a96-bd760979c0bf
Public Version Date: September 12, 2023
Public Version Number: 2
DI Record Publish Date: September 01, 2023