THD PressKit 800146

GUDID 08033737711309

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.

THD SPA

Gastrointestinal motility manometric catheter, non-electronic
Primary Device ID08033737711309
NIH Device Record Keyef6dfce6-66d3-4726-8ee8-4d7e420a1db9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHD PressKit
Version Model NumberTHD PressKit (FL ENV)
Catalog Number800146
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
GS108033737711309 [Primary]
GS118033737711306 [Package]
Package: Cartoon Box [1 Units]
In Commercial Distribution
GS128033737711303 [Package]
Package: Cartoon Box [25 Units]
In Commercial Distribution
GS128033737711365 [Package]
Contains: 28033737711303
Package: Cartoon Box [2 Units]
In Commercial Distribution
GS128033737711396 [Package]
Contains: 28033737711303
Package: Cartoon Box [4 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 Date2017-09-21

On-Brand Devices [THD PressKit]

08033737711309THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) a
08033737711293THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) a
28033737711334THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) a
08033737711262THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) a
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