Identity
- Trade Name
- THD REVOLUTION FDA UDI
- Generic Name
- Invasive vascular ultrasound system FDA UDI
- Device Name
- THD Revolution is an electromedical device which, combined with the THD Kits, makes it possible to perform ligation of the haemorrhoidal arteries using a Doppler probe and subsequent mucopexy to correct prolapse. THD Revolution is equipped with a Doppler module with high sensitivity digital signal processing, with automatic reduction of background noise. The device is equipped with a display for monitoring operations, to guide the operator through the various settings, to provide information on the status of the device and any accessories connected to it. Device functions are easily operated through the buttons on the front. FDA UDI
- Model / Reference
- THD REVOLUTION (US) FDA UDI
- Description
- THD Revolution is an electromedical device which, combined with the THD Kits, makes it possible to perform ligation of the haemorrhoidal arteries using a Doppler probe and subsequent mucopexy to correct prolapse. THD Revolution is equipped with a Doppler module with high sensitivity digital signal processing, with automatic reduction of background noise. The device is equipped with a display for monitoring operations, to guide the operator through the various settings, to provide information on the status of the device and any accessories connected to it. Device functions are easily operated through the buttons on the front. FDA UDI
Identifiers
- Catalog Number
- 800139 FDA UDI
- Primary DI / UDI-DI
- 18033737710842 FDA UDI
- 510(k) Number
- K141657 FDA UDI
- FDA Product Code
- JAF FDA UDI
- GMDN Term
- Invasive vascular ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1540 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
Yes
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
No
FDA UDI
Category: Invasive vascular ultrasound system
Thd Revolution by Thd Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Thd Spa
Sources (1)
- FDA UDI def41be8-4bf3-4747-9de8-9e4524799deb 36 fields · synced Jun 1, 2026