THD Procto Software System

Basic Information

• Brand Name: THD Procto Software System
• Primary DI: 08033737713037
• Version / Model: THD Procto Software
• Catalog Number: 760004
• Company Name: THD SPA
• Labeler DUNS: 338430324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-19
• Public Version: 1
• Public Version Date: 2021-07-27
• Public Version Status: New
• Public Device Record Key: b28f8c20-1d0e-4e1d-9e13-61546e0b15ad

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
KLA	Monitor, Esophageal Motility, And Tube	Gastroenterology, Urology	876.1725	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
FWG	Camera, Television, Endoscopic, With Audio	General, Plastic Surgery	878.4160	1
OUG	Medical Device Data System	General Hospital	880.6310	1
NSX	Software, Transmission And Storage, Patient Data

GMDN Terms

Code	Name	Definition	Implantable	Status
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033737713037	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211623	000