Duns Number:338430324
Device Description: THD Revolution is an electromedical device which, combined with the THD Kits, makes it pos 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.
Catalog Number
800139
Brand Name
THD REVOLUTION
Version/Model Number
THD REVOLUTION (US)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141657
Product Code
JAF
Product Code Name
Monitor, Ultrasonic, Nonfetal
Public Device Record Key
def41be8-4bf3-4747-9de8-9e4524799deb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 14, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |