Identity
- Trade Name
- Disposable Electrode Serie FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Model / Reference
- P0015 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06924274952701 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
The Disposable Electrode Serie is a high-quality, single-use open-surgery electrosurgical electrode designed for general plastic surgery procedures. Made from advanced materials and featuring a unique attachment mechanism, it provides precise cutting and coagulation capabilities.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang Shuyou Surgical Instrument Co., Ltd.
Sources (1)
- FDA UDI 0ea82a6c-3bb5-4e7c-9a88-e8c21367db2f 32 fields · synced Jul 31, 2026