THD PressKit - THD PressKit is a practical and completely - THD SPA

Duns Number:338430324

Device Description: THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessPr THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) and an anoscope (THD n-Ano) that, in combination with the THD Anopress allows a handy and safely execution of the THD Anal manometry. 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.THD n-ano is a compact and manageable anoscope with an integrated LED light, completely disposable and packed individually. The reduced diameter and the atraumatic profile make the anoscope the ideal tool for a comfortable examination for both doctor and patient.

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More Product Details

Catalog Number

800142

Brand Name

THD PressKit

Version/Model Number

THD PressKit (TR BOX)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

Product Code Details

Product Code

KLA

Product Code Name

Monitor, Esophageal Motility, And Tube

Device Record Status

Public Device Record Key

6d1ec9a9-a9ba-400c-97e4-d2d3eefa6c41

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2017

Additional Identifiers

Package DI Number

28033737711266

Quantity per Package

5

Contains DI Package

08033737711262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cartoon Box

"THD SPA" Characteristics
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