Identity
- Trade Name
- VESALIUS tungsten round loop FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
- Model / Reference
- D=0,14mm d=6mm L=25mm FDA UDI
Identifiers
- Catalog Number
- 2603001 FDA UDI
- Primary DI / UDI-DI
- 08034055292044 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, reusable 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Open-surgery electrosurgical electrode, monopolar, reusable
The VESALIUS tungsten round loop is a versatile electrosurgical device designed for general, plastic surgery procedures. It features a reusable design with a variety of electrode configurations and requires patient contact return electrodes to complete the circuit. The device has been published in [Country/Region] and is available for commercial distribution. With its map-identified as an invasive, monopolar, electrical conductor, this device is intended to be attached to an electrosurgical handpiece during open surgical procedures. It may also be used with other medical devices, requiring a patient contact return electrode.
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, reusable.
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Cameron-Miller — Cameron-Miller, Inc. · Class II
- MicroFrance® — Integra Microfrance · Class II
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
- Bipolar Forceps — BLACK & BLACK SURGICAL, INC. · Class II
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- Cameron-Miller — Cameron-Miller, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Telea Electronic Engeenering Srl
Sources (1)
- FDA UDI 7284bc9c-5124-4713-a490-fea7aca27805 33 fields · synced Jul 15, 2026