FDA UDI
In Commercial Distribution
🇺🇸 United States
Peng’s Multifunctional Operative Dissector(PMOD)
DI: 06924274958086
·
Model: SY-IB-1
·
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Peng’s Multifunctional Operative Dissector(PMOD)
- Primary DI
- 06924274958086
- Version / Model
- SY-IB-1
- 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
- 2023-04-27
- Public Version
- 1
- Public Version Date
- 2023-05-05
- Public Version Status
- New
- Public Device Record Key
- 3129f074-db35-436f-8831-0a746ec3f727
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 |
|---|---|---|---|---|
| 44681 | Electrosurgical handpiece, single-use | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16924274958083 | GS1 | 6 | Not in Commercial Distribution | 2023-04-27 | |
| Primary | 06924274958086 | GS1 | ||||
| Package | 26924274958080 | GS1 | 240 | Not in Commercial Distribution | 2023-04-27 | |
| Package | 36924274958087 | GS1 | 2400 | Not in Commercial Distribution | 2023-04-27 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040780 | 000 |