FDA UDI
In Commercial Distribution
🇺🇸 United States
BONSS
DI: 06927155387104
·
Model: MC403A
·
Jiangsu Bonss Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BONSS
- Primary DI
- 06927155387104
- Version / Model
- MC403A
- Company Name
- Jiangsu Bonss Medical Technology Co., Ltd.
- Labeler DUNS
- 543429834
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-02
- Public Version
- 1
- Public Version Date
- 2024-11-11
- Public Version Status
- New
- Public Device Record Key
- 3de23898-3aaa-4ce2-89c3-9097bf444094
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 63308 | Electrolytic-plasma electrosurgical system | An assembly of devices intended to use radio-frequency (RF) alternating current in a bipolar configuration to excite electrolytes within a solution (typically saline) to create a focused, charged plasma sphere for cutting and coagulation of soft tissues during an endoscopic or open surgical procedure. The assembly includes a mains electricity (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and bipolar electrodes to apply the energy to the surgical site. It is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system) and is not intended for argon-enhanced electrosurgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06927155387104 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221743 | 000 |