THD Procto Software System 800309

GUDID 68051887043325

THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry and Transanal Ultrasound. THD DIGITAL MOBILE ADVANCED has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes, THD Anopress (transportable anorectal manometer) for anorectal manometry and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.

THD SPA

Ultrasound imaging system application software
Primary Device ID68051887043325
NIH Device Record Keye45243ec-a8e4-4814-bde2-0a12a4b6337c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHD Procto Software System
Version Model NumberTHD DIGITAL MOBILE ADVANCED
Catalog Number800309
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
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 Identifiers

Device Issuing AgencyDevice ID
GS168051887043325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-22
Device Publish Date2023-12-14

On-Brand Devices [THD Procto Software System]

18033737712389THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal
08033737713037The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic f
58051887042642THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathol
18033737712341THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution usi
68051887043325THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal S
68051887043318THD DIGITAL MOBILE ECOGRAPHY is an integrated mobile proctological platform for the Colo-Rectal
68051887043301THD DIGITAL MOBILE MANOMETRY is an integrated mobile proctological platform for the Colo-Rectal
68051887043295THD DIGITAL MOBILE is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ P

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