THD PressProbe 800144

GUDID 28033737711372

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.

THD SPA

Gastrointestinal motility manometric catheter, non-electronic
Primary Device ID28033737711372
NIH Device Record Key476b6e7d-5867-480b-b3d9-3d8ce67f5f67
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHD PressProbe
Version Model NumberTHD PressProbe (Env)
Catalog Number800144
Company DUNS338430324
Company NameTHD SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com

Device Dimensions

Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram
Length165 Millimeter
Outer Diameter16 Millimeter
Weight25 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS108033737711286 [Primary]
GS118033737711283 [Package]
Contains: 08033737711286
Package: Cartoon Box [1 Units]
In Commercial Distribution
GS128033737711280 [Package]
Contains: 08033737711286
Package: Cartoon Box [50 Units]
In Commercial Distribution
GS128033737711341 [Package]
Contains: 28033737711280
Package: Cartoon Box [1 Units]
In Commercial Distribution
GS128033737711372 [Package]
Contains: 28033737711280
Package: Cartoon Box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLAMonitor, Esophageal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-08-05
Device Publish Date2017-09-20

On-Brand Devices [THD PressProbe]

28033737711372THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. Th
08033737711255THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. Th
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