THD SensyProbe 710010

GUDID 08033737712290

THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform a THD anorectal manometry examination. THD SensyProbe allows measuring of the actual mean sphincter tone pressure in the various functional activations (resting, squeeze and strain tone). In addition, thanks to a balloon fitted at the end of the probe and connection via a dedicated line, THD SensyProbe allows analysing the rectal ampulla volume and hence assessing rectal sensitivity and anorectal inhibitory reflex (this measurement can be made after inflating the balloon with the dedicated THD SensyProbe Accessory). THD SensyProbe does not need to be calibrated, as this is automatically done each time a procedure with THD Anopress is started. The probe is equipped with an ergonomic grip and has a fully atraumatic tip ensuring maximum comfort for the medical staff and the patient during the examination, and it has been dimensioned so as to reproduce the conditions during a normal digital exploration. A Probe Card to record the examination is included in the package.

THD SPA

Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic
Primary Device ID08033737712290
NIH Device Record Key4b079b25-f351-4269-b443-1e836d7238b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHD SensyProbe
Version Model NumberTHD SensyProbe
Catalog Number710010
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

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108033737712290 [Primary]
GS128033737712287 [Package]
Package: Cartoon Box [1 Units]
In Commercial Distribution
GS138033737712284 [Package]
Package: Cartoon Box [15 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 Number3
Public Version Date2022-08-05
Device Publish Date2018-03-20

On-Brand Devices [THD SensyProbe]

08033737712306THD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provided wit
08033737712290THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.