Identity
- Trade Name
- Radio Frequency System FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Model / Reference
- RF-301 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976264730073 FDA UDI
- 510(k) Number
- K231749 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Percutaneous radio-frequency ablation system generator
Radio Frequency System by Shenzhenshi Sincoheren S&T Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Percutaneous radio-frequency ablation system generator.
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Cleared under the same submission
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
- Shenzhenshi Sincoheren S&T Development Co., Ltd.
Sources (1)
- FDA UDI 9e17f6df-1061-4e39-bbe6-8ec0ba72bfc2 33 fields · synced Jun 8, 2026