FDA UDI
In Commercial Distribution
🇺🇸 United States
PlasmaJet Neutral Plasma Surgery System
DI: M3970SCP0512H0
·
Model: OS-CP 05-12H
·
PLASMA SURGICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PlasmaJet Neutral Plasma Surgery System
- Primary DI
- M3970SCP0512H0
- Version / Model
- OS-CP 05-12H
- Catalog Number
- OS-CP 05-12H
- Company Name
- PLASMA SURGICAL, INC
- Labeler DUNS
- 360799048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-18
- Public Version
- 4
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 83bdc04c-0307-42e6-9465-61a588868cf3
Device Description
Single-use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 47275 | Plasma surgical system handpiece | A hand-held instrument used with a plasma surgical system control unit to coagulate, cut, and/or vaporize/ablate tissue during open and/or laparoscopic surgery. Inert argon (Ar) gas is excited (ionized) in the instrument by a series of internal bipolar electrodes to generate plasma (atomic ions and free electrons) which emerges from the tip of the handpiece in a stream to release kinetic and thermal energy upon contact with tissue. Operation is regulated using a hand-control on the instrument or via a connected foot-switch. The instrument is typically in the form of a pen/pencil with attached cables for connection to the control unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M397OSCP0512H2 | HIBCC | BOX | 5 | In Commercial Distribution | |
| Primary | M3970SCP0512H0 | HIBCC |
Customer Contacts
- Phone
- 1 678 578 4390
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121977 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12 | Centimeter |