Duns Number:338430324
Device Description: THD PressProbe is a disposable active probe for the execution of the THD Anal manometry ex THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress.The probe has an ergonomic grip and a completely atraumatic profile, which ensures the maximum comfort for both doctor and patient during the examintaion and it has been designed in order to reproduce a normal digital examination.Each pack contains a proprietary Probe Card, to enable the recording of the examination.
Catalog Number
800144
Brand Name
THD PressProbe
Version/Model Number
THD PressProbe (Env)
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"
Yes
For Single-Use
Yes
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
K161785,K161785,K161785,K161785,K161785
Product Code
KLA
Product Code Name
Monitor, Esophageal Motility, And Tube
Public Device Record Key
476b6e7d-5867-480b-b3d9-3d8ce67f5f67
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 20, 2017
Package DI Number
28033737711372
Quantity per Package
2
Contains DI Package
28033737711280
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cartoon Box
| 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 |