Identity
- Trade Name
- Virtue RF Microneedle Cartridge FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Model / Reference
- SmartRF 36PIN TIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017100722 FDA UDI
- 510(k) Number
- K150409 FDA UDI
- FDA Product Code
- OUH FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system 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
Yes
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: Radio-frequency skin surface treatment system
Virtue RF Microneedle Cartridge by shenb Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K150409 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- shenb Co., Ltd.
Sources (2)
- FDA UDI 5f7aa95e-56e1-4f1a-921e-743f25aeaf7c 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026