FDA UDI
In Commercial Distribution
🇺🇸 United States
J-PLASMA®
DI: 00607151007812
·
Model: GS-018C
·
BOVIE MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- J-PLASMA®
- Primary DI
- 00607151007812
- Version / Model
- GS-018C
- Catalog Number
- GS-018C
- Company Name
- BOVIE MEDICAL CORPORATION
- Labeler DUNS
- 079940465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- 5677c091-dc72-49a2-a946-dd9a50921aff
Device Description
J-PLASMA® HANDPIECE WITH CABLE OPEN - 18MM
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
- Yes
- 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 |
|---|---|---|---|---|
| 58039 | Endoscopic electrosurgical handpiece/electrode, monopolar, single-use | A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607151007819 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 00607151007812 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112233 | 000 |