FDA UDI
In Commercial Distribution
🇺🇸 United States
ELECTROCYN soma (nurodermis)
DI: 09551012610325
·
Model: ES1301W
·
V3BIO SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELECTROCYN soma (nurodermis)
- Primary DI
- 09551012610325
- Version / Model
- ES1301W
- Catalog Number
- ES1301W
- Company Name
- V3BIO SDN. BHD.
- Labeler DUNS
- 659301481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-26
- Public Version
- 1
- Public Version Date
- 2024-03-05
- Public Version Status
- New
- Public Device Record Key
- 0e71ac93-7567-4749-a68e-b1d3ef75ba3f
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09551012610325 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 30 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius