AccessGUDID - DEVICE: ELECTROCYN soma (nurodermis) (09551012610332)

GUDID

Device Identifier (DI) Information

Brand Name: ELECTROCYN soma (nurodermis)
Version or Model: ES3301W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES3301W
Company Name: V3BIO SDN. BHD.

Primary DI Number: 09551012610332
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 659301481 *Terms of Use

Device Description: ELECTROCYN soma (nurodermis) for dermal wound cleansing is a stabilized electro-activated super oxidized water-based solution (EASW) under product family of ELECTROCYN soma. It is suitable for cleansing of dermal and other superficial wounds. ELECTROCYN soma (nurodermis) is non-irritant and ready to use.

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: No 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: f4c566ba-d379-4499-9151-dc04ea059b8e
Public Version Date: March 05, 2024
Public Version Number: 1
DI Record Publish Date: February 26, 2024