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

• Primary Device ID: 08033737712290
• NIH Device Record Key: 4b079b25-f351-4269-b443-1e836d7238b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD SensyProbe
• Version Model Number: THD SensyProbe
• Catalog Number: 710010
• Company DUNS: 338430324
• Company Name: THD SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com
• Phone: +390522634311
• Email: Regulatory@thdlab.com

Device Dimensions

• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram
• Length: 165 Millimeter
• Outer Diameter: 16 Millimeter
• Weight: 25 Gram

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033737712290 [Primary]
GS1	28033737712287 [Package]; Package: Cartoon Box [1 Units]; In Commercial Distribution
GS1	38033737712284 [Package]; Package: Cartoon Box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180135

FDA Product Code

• KLA: Monitor, Esophageal Motility, And Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-08-05
• Device Publish Date: 2018-03-20

On-Brand Devices [THD SensyProbe]

• 08033737712306: THD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provided wit
• 08033737712290: THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform