FDA UDI
In Commercial Distribution
🇺🇸 United States
THD REVOLUTION
DI: 18033737710842
·
Model: THD REVOLUTION (US)
·
THD SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- THD REVOLUTION
- Primary DI
- 18033737710842
- Version / Model
- THD REVOLUTION (US)
- Catalog Number
- 800139
- Company Name
- THD SPA
- Labeler DUNS
- 338430324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- def41be8-4bf3-4747-9de8-9e4524799deb
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | Radiology | 892.1540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61227 | Invasive vascular ultrasound system | A mains electricity (AC-powered) device assembly designed to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/Doppler/transit time technology during procedures involving vascular surgery. It may also provide additional measurements (e.g., blood pressure, vascular resistance). It consists of a mobile (on wheels) control unit with graphical user-interface, typically placed outside the sterile field; and an attached, reusable, sterilizable probe intended to be used within the body (invasive) but not within the lumen of the blood vessel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18033737710842 | GS1 |
Customer Contacts
- Phone
- +390522634311
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141657 | 000 |