FDA UDI
In Commercial Distribution
🇺🇸 United States
PlasmaJet Neutral Plasma Surgery System
DI: M397PS102130RO0
·
Model: PS10-2130-RO
·
PLASMA SURGICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PlasmaJet Neutral Plasma Surgery System
- Primary DI
- M397PS102130RO0
- Version / Model
- PS10-2130-RO
- Catalog Number
- PS10-2130-RO
- Company Name
- PLASMA SURGICAL, INC
- Labeler DUNS
- 360799048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-01
- Public Version
- 2
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- fe03b0f7-b9fc-4716-8f9e-91a491b13a1d
Device Description
PlasmaJet V3 Plus Console System (Romania)
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 | M397PS102130RO0 | HIBCC |
Customer Contacts
- Phone
- 6785784390
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121977 | 000 |