THD Procto Software System 800299

GUDID 58051887042642

THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions. Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound.

THD SPA

Ultrasound imaging system application software
Primary Device ID58051887042642
NIH Device Record Key363ab120-d4d8-460f-8102-3ef0ac40a440
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHD Procto Software System
Version Model NumberTHD HRStation
Catalog Number800299
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 Batchtrue
Serial Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS158051887042642 [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 Date2022-10-17
Device Publish Date2022-10-07

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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