THD Procto Software System 760004

GUDID 08033737713037

The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for: - Endoanal ultrasound (trans-rectal ultrasound / echography) - Anoscopy exams - Manometry exams

THD SPA

Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software
Primary Device ID08033737713037
NIH Device Record Keyb28f8c20-1d0e-4e1d-9e13-61546e0b15ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHD Procto Software System
Version Model NumberTHD Procto Software
Catalog Number760004
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS108033737713037 [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 Date2021-07-27
Device Publish Date2021-07-19

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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