FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Electrode Serie
DI: 06924274954705
·
Model: OB-2020
·
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Electrode Serie
- Primary DI
- 06924274954705
- Version / Model
- OB-2020
- Company Name
- Zhejiang Shuyou Surgical Instrument Co.,Ltd.
- Labeler DUNS
- 421340711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-14
- Public Version
- 5
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 4025907e-b6d8-46e5-9837-755e28de812b
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 |
|---|---|---|---|---|
| 61874 | Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 06924274954736 | GS1 | 10 | In Commercial Distribution | ||
| Package | 06924274954729 | GS1 | 10 | In Commercial Distribution | ||
| Package | 06924274954712 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 06924274954705 | GS1 | ||||
| Package | 06924274954743 | GS1 | 20 | In Commercial Distribution |