Identity
- Trade Name
- SURGITRON 4.0 DUAL RF/90 FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- SURGITRON 4.0 DUAL RF/90 IEC 110V FDA UDI
- Model / Reference
- IEC3A-S30-90/110 FDA UDI
- Description
- SURGITRON 4.0 DUAL RF/90 IEC 110V FDA UDI
Identifiers
- Catalog Number
- IEC3A-S30-90/110 FDA UDI
- Primary DI / UDI-DI
- 00841494106690 FDA UDI
- 510(k) Number
- K013255 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system
Surgitron 4.0 Dual Rf/90 by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K013255 also covers:
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
- Cynosure, LLC
Sources (1)
- FDA UDI 1d273bde-29f4-466a-a3bb-ed8559316c3f 35 fields · synced May 30, 2026