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 ID: 58051887042642
• NIH Device Record Key: 363ab120-d4d8-460f-8102-3ef0ac40a440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD Procto Software System
• Version Model Number: THD HRStation
• Catalog Number: 800299
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	58051887042642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211623

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-17
• Device Publish Date: 2022-10-07

On-Brand Devices [THD Procto Software System]

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