FDA UDI
In Commercial Distribution
🇺🇸 United States
PlazMagik
DI: 08800067700248
·
Model: PlazMagik
·
AGNES MEDICAL CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PlazMagik
- Primary DI
- 08800067700248
- Version / Model
- PlazMagik
- Company Name
- AGNES MEDICAL CO., LTD.
- Labeler DUNS
- 987426048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-16
- Public Version
- 2
- Public Version Date
- 2026-04-28
- Public Version Status
- Update
- Public Device Record Key
- 746ab9d5-c455-4128-ac3c-6d4177d0ec2f
Device Description
PlazMagik is an electro-surgical device for use in dermatological applications
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47273 | Plasma surgical system | An assembly of electrically-powered devices designed to generate a fine plasma jet used to coagulate, cut, and/or vaporize/ablate tissue and/or reduce inflammation/promote healing during open, laparoscopic or topical surgery. The system has a gas [e.g., argon (Ar)] supply or an ambient air input, and typically includes a control unit, a handpiece(s) with connection cable and foot-switch. The plasma [e.g., argon (Ar), nitric oxide] is generated in the handpiece and is applied to tissue where the surgical effect is achieved without passing electric current through the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800067700248 | GS1 |
Customer Contacts
- Phone
- +823180209717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230837 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity