FDA UDI
In Commercial Distribution
🇺🇸 United States
Peng's Multifunctional Operative Dissectors (Electrosurgical Pencil)
DI: 06924274957638
·
Model: 3810T
·
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Peng's Multifunctional Operative Dissectors (Electrosurgical Pencil)
- Primary DI
- 06924274957638
- Version / Model
- 3810T
- 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
- 2021-10-19
- Public Version
- 1
- Public Version Date
- 2021-10-27
- Public Version Status
- New
- Public Device Record Key
- b8275a79-740c-406b-a74b-a8c6fdf82753
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 61869 | Open-surgery electrosurgical handpiece/electrode, monopolar, single-use | A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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 | 16924274957635 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 06924274957638 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040780 | 000 |