AccessGUDID - DEVICE: THD SensyProbe (08033737712290)

GUDID

Device Identifier (DI) Information

Brand Name: THD SensyProbe
Version or Model: THD SensyProbe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 710010
Company Name: THD SPA

Primary DI Number: 08033737712290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17745	Gastrointestinal motility manometric catheter, non-electronic	A non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLA	Monitor, Esophageal Motility, And Tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180135	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 165 Millimeter
Outer Diameter: 16 Millimeter
Weight: 25 Gram

Device Record Status

Public Device Record Key: 4b079b25-f351-4269-b443-1e836d7238b3
Public Version Date: August 05, 2022
Public Version Number: 3
DI Record Publish Date: March 20, 2018